Recall events
/
Event 71973
Event summary
Timeline bucket July 28, 2015
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording Ohm Laboratories, Inc.
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
21 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 21
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
D-0019-2016
Recall number D-0019-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 8,735 units
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2644273, Exp 9/30/2016; 2600127, Exp 3/20/2016; 2544486, Exp 7/31/2016
Distribution pattern Nationwide.
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[8343]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 21
Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
D-0020-2016
Recall number D-0020-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 90,410 units
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2658137, Exp 11/30/2016; 2644272, Exp 9/30/2016; 2625093, 2625092 Exp 6/30/2016; 2617892, Exp 5/31/2016; 2610783, Exp 4/30/2016; 2600126, 2600128, Exp 2/29/2016 b) 2625093, Exp 6/30/2016; 2617892, Exp 5/31/2016; 2600128, Exp 2/29/2016
Distribution pattern Nationwide.
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[8354]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 21
Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
D-0021-2016
Recall number D-0021-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 18576 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2625092, Exp 6/30/2016; 2644265, Exp 9/30/2016; 2600126, Exp 2/29/2016
Distribution pattern Nationwide.
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[8187]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 21
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
D-0022-2016
Recall number D-0022-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 21,356 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: (a) 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Distribution pattern Nationwide.
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[8172]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 21
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
D-0023-2016
Recall number D-0023-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 291,312 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2644273, 2644265, Exp 9/30/2016; 2617891, 2617892, 2617893, Exp 5/31/2016; 2625093, 6/30/2016; 2544488, 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2610783, Exp 4/30/2016 b) 2600128, Exp 2/29/2016; 2544487, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016; 2644272, Exp 9/30/2016; 2658138, Exp 11/30/2016
Distribution pattern Nationwide.
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[9409]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 21
Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.
D-0024-2016
Recall number D-0024-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 4,176 units
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2617892, Exp 5/31/2016
Distribution pattern Nationwide.
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[8163]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 21
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA
D-0025-2016
Recall number D-0025-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 43,344 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016; 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016
Distribution pattern Nationwide.
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[9197]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 21
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
D-0026-2016
Recall number D-0026-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 12,960 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2544486, 2544487, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2658140, Exp 11/30/2016
Distribution pattern Nationwide.
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[6882]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 21
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087
D-0027-2016
Recall number D-0027-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity N/A
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2625092, Exp 6/30/2016; 2610783, Exp 4/30/2016 b) 2625093, Exp 6/30/2016, 2610783, Exp 4/30/2016
Distribution pattern Nationwide.
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[6505]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 21
Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9
D-0028-2016
Recall number D-0028-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 35,712 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2544488, Exp, 7/31/2016; 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016
Distribution pattern Nationwide.
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[8170]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 21
HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
D-0029-2016
Recall number D-0029-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 25,488 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2544486, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2617891, Exp 5/31/2016; 2644265, Exp 9/30/2016
Distribution pattern Nationwide.
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[8337]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 21
Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
D-0030-2016
Recall number D-0030-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 9,624 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016
Distribution pattern Nationwide.
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[8152]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 21
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
D-0031-2016
Recall number D-0031-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 29,360 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2644265, Exp 9/30/2016; 2658140, Exp 11/30/2016; 2625092, 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544488, 2544486, Exp 7/31/2016
Distribution pattern Nationwide.
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[9406]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 21
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
D-0032-2016
Recall number D-0032-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 311 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Distribution pattern Nationwide.
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[6481]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 21
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
D-0033-2016
Recall number D-0033-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 11,232 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2600126, Exp 2/29/2016; 2644273, Exp 9/30/2016
Distribution pattern Nationwide.
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[8967]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 21
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
D-0034-2016
Recall number D-0034-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 33,984 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2658140, Exp 11/30/2016; 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; b) 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016
Distribution pattern Nationwide.
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[8161]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 21
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.
D-0035-2016
Recall number D-0035-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 53,688 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2600127, Exp 2/29/2016; 2617892, Exp 5/31/2016; 2644265, 9/30/2016; 2625092, Exp, 6/30/2016; 2658140, Exp 11/30/2016. b) 2617892, Exp 5/31/2016; 2610783, 4/30/2016; 2644272, Exp 9/30/2016
Distribution pattern Nationwide.
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[9189]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 21
Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
D-0036-2016
Recall number D-0036-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 34,488 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: 2617892, 2617893, Exp 5/31/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, Exp 11/30/2016
Distribution pattern Nationwide.
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[6898]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 21
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
D-0037-2016
Recall number D-0037-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity N/A
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: (a) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, Exp 9/30/2016
Distribution pattern Nationwide.
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[9399]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 21
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015
D-0038-2016
Recall number D-0038-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 329,748 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Numbers: a) 2625093, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2658137, 2658140, Exp 11/30/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544487, 2544488, Exp 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2644272, 2644273, 2644265, Exp 9/30/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, 2658140 Exp 11/30/2016; 2610783, Exp 4/30/2016; 2617891, Exp 5/31/2016.
Distribution pattern Nationwide.
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[8179]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 21
Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
D-0039-2016
Recall number D-0039-2016
Initiated July 28, 2015
Classification Class III
Status Terminated
Quantity 5,040 boxes
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: Out Of Specification (OOS) result for Assay.
Code information Batch Number: 2610783, Exp 4/30/2016
Distribution pattern Nationwide.
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[6491]
FDA event record
· Exact recall-number query on openFDA
