Recall events
/
Event 80750
Event summary
Timeline bucket August 03, 2018
Product types Drug
Classifications Class I, Class II, and Class III
Statuses Terminated
Recalling firm wording Product Quest Manufacturing LLC
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
54 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 54
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
D-0027-2019
Recall number D-0027-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 5025 sticks
App-derived interpretation
Microbial contamination
reason.microbial_contamination · v1.0.0
Microbial Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Code information Lot: 172428G
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8202]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 54
Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1.
D-0028-2019
Recall number D-0028-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 4040 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10526]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 54
CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.
D-0029-2019
Recall number D-0029-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 4464 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10475]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 54
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
D-0030-2019
Recall number D-0030-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 529,536 cans
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10427]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 54
CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465.
D-0031-2019
Recall number D-0031-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 552 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8193]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 54
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
D-0032-2019
Recall number D-0032-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 277,587 cans
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8188]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 54
CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.
D-0033-2019
Recall number D-0033-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 42,792 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10512]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 54
CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
D-0034-2019
Recall number D-0034-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 285,840 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10155]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 54
CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.
D-0035-2019
Recall number D-0035-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 552 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10051]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 54
Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256
D-0036-2019
Recall number D-0036-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 21,492 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10086]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 54
DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
D-0037-2019
Recall number D-0037-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 786,720 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10080]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 54
FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
D-0038-2019
Recall number D-0038-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 46,056 cans
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10444]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 54
Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
D-0039-2019
Recall number D-0039-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 5040 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10514]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 54
Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.
D-0040-2019
Recall number D-0040-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 39,924 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7830]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 54
meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .
D-0041-2019
Recall number D-0041-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 182,568 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10497]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 54
Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.
D-0042-2019
Recall number D-0042-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 37,464 cans
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7848]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 54
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
D-0043-2019
Recall number D-0043-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 3264 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10041]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 54
Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
D-0044-2019
Recall number D-0044-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 8592 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10090]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 54
Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01519 9.
D-0045-2019
Recall number D-0045-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 9024 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10436]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 54
Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.
D-0046-2019
Recall number D-0046-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 10,584 cans
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10480]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 54
Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
D-0047-2019
Recall number D-0047-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 4992 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10516]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 54
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.
D-0048-2019
Recall number D-0048-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 102,348 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10162]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 54
QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.
D-0049-2019
Recall number D-0049-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 4,200 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10138]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 54
QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.
D-0050-2019
Recall number D-0050-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 172,800 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10077]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 54
Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1.
D-0051-2019
Recall number D-0051-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 114,336 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10168]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 54
Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.
D-0052-2019
Recall number D-0052-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 16,944 cans
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10047]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 54
Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
D-0053-2019
Recall number D-0053-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 22,392 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10135]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 54
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
D-0054-2019
Recall number D-0054-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 7,488 tubes
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10408]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 54
OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.
D-0055-2019
Recall number D-0055-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 3,442,536 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10507]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 54
Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7.
D-0056-2019
Recall number D-0056-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 2,112 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10141]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 54
Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7.
D-0057-2019
Recall number D-0057-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 1008 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10464]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 54
Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 59895 4.
D-0058-2019
Recall number D-0058-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 3,600 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7866]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 54
Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
D-0059-2019
Recall number D-0059-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 30,096 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8206]
FDA event record
· Exact recall-number query on openFDA
drug · product 34 of 54
Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1.
D-0060-2019
Recall number D-0060-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 141,888 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7855]
FDA event record
· Exact recall-number query on openFDA
drug · product 35 of 54
Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7.
D-0061-2019
Recall number D-0061-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 286,176 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10472]
FDA event record
· Exact recall-number query on openFDA
drug · product 36 of 54
Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.
D-0062-2019
Recall number D-0062-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 361,104 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10518]
FDA event record
· Exact recall-number query on openFDA
drug · product 37 of 54
Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
D-0063-2019
Recall number D-0063-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 355,056 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10044]
FDA event record
· Exact recall-number query on openFDA
drug · product 38 of 54
Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.
D-0064-2019
Recall number D-0064-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 533,016 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10502]
FDA event record
· Exact recall-number query on openFDA
drug · product 39 of 54
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
D-0065-2019
Recall number D-0065-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 9,480 tubes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Stability Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Stability Specifications: separation of product and failure for actives.
Code information Lot: 161223D, Exp. 4/16/2019
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10161]
FDA event record
· Exact recall-number query on openFDA
drug · product 40 of 54
FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
D-0066-2019
Recall number D-0066-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 6,109 cans
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Superpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Superpotent Drug: high out of specification assay results for the camphor ingredient.
Code information Lot: 170498B, Exp. 02/23/2020
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[7861]
FDA event record
· Exact recall-number query on openFDA
drug · product 41 of 54
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
D-0067-2019
Recall number D-0067-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 5,004 tubes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Code information Lot: 170591E, Exp. 11/17/18
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8198]
FDA event record
· Exact recall-number query on openFDA
drug · product 42 of 54
Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
D-0068-2019
Recall number D-0068-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 4,692 tubes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Superpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Superpotent Drug: high out of specification assay results for the menthol ingredient.
Code information Lot. 172598G, Exp. 7/4/2019
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10172]
FDA event record
· Exact recall-number query on openFDA
drug · product 43 of 54
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
D-0069-2019
Recall number D-0069-2019
Initiated August 03, 2018
Classification Class III
Status Terminated
Quantity 6,516 tubes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Code information Lot: 163241K, Exp. October 2018
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10073]
FDA event record
· Exact recall-number query on openFDA
drug · product 44 of 54
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
D-0070-2019
Recall number D-0070-2019
Initiated August 03, 2018
Classification Class III
Status Terminated
Quantity 7,944 tubes
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Code information Lot: 163241K, Exp. October 2018
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10032]
FDA event record
· Exact recall-number query on openFDA
drug · product 45 of 54
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
D-0071-2019
Recall number D-0071-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 25,596 sticks
App-derived interpretation
Microbial contamination
reason.microbial_contamination · v1.0.0
Microbial Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Code information Lot: PSP85W/172792H
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10504]
FDA event record
· Exact recall-number query on openFDA
drug · product 46 of 54
Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
D-0072-2019
Recall number D-0072-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 1,440 tubes
App-derived interpretation
Microbial contamination
reason.microbial_contamination · v1.0.0
Microbial Contamination
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Code information Lot: 161794F
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10033]
FDA event record
· Exact recall-number query on openFDA
drug · product 47 of 54
CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
D-0073-2019
Recall number D-0073-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity 11,016 cans
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Subpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Code information Lot: 170591E, Exp. 11/17/18
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10521]
FDA event record
· Exact recall-number query on openFDA
drug · product 48 of 54
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
D-0074-2019
Recall number D-0074-2019
Initiated August 03, 2018
Classification Class I
Status Terminated
Quantity 16 bottles
App-derived interpretation
Microbial contamination
reason.microbial_contamination · v1.0.0
Microbial Contamination
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Code information Lot: 173089J Exp. 09/19
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[8184]
FDA event record
· Exact recall-number query on openFDA
drug · product 49 of 54
Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
D-0075-2019
Recall number D-0075-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity Unknown
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10152]
FDA event record
· Exact recall-number query on openFDA
drug · product 50 of 54
Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
D-0076-2019
Recall number D-0076-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity Unknown
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10088]
FDA event record
· Exact recall-number query on openFDA
drug · product 51 of 54
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
D-0077-2019
Recall number D-0077-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity Unknown
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10500]
FDA event record
· Exact recall-number query on openFDA
drug · product 52 of 54
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
D-0078-2019
Recall number D-0078-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity Unknown
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10143]
FDA event record
· Exact recall-number query on openFDA
drug · product 53 of 54
Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
D-0079-2019
Recall number D-0079-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity Unknown
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10167]
FDA event record
· Exact recall-number query on openFDA
drug · product 54 of 54
Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
D-0080-2019
Recall number D-0080-2019
Initiated August 03, 2018
Classification Class II
Status Terminated
Quantity Unknown
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information All lots remaining within expiry.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[10030]
FDA event record
· Exact recall-number query on openFDA
