Recall events
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Event 89334
Event summary
Timeline bucket January 26, 2022
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording ULTRAtab 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
33 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 33
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
D-0523-2022
Recall number D-0523-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 33,758,436 tablets
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
Code information Product Code C106L; Bulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, Product Code C106LA; Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14735]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 33
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
D-0524-2022
Recall number D-0524-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 19,103,287 tablets
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
Code information Product Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14726]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 33
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
D-0525-2022
Recall number D-0525-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 1,798,048 tablets
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
Code information Product Codes: C111L Bulk Lot: 18L028
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14774]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 33
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
D-0526-2022
Recall number D-0526-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 639,729 tablets
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
Code information Product Codes: C119L Bulk Lots: 18K028
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14977]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 33
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
D-0527-2022
Recall number D-0527-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 917,304 tablets
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
Code information Product Codes: C121L Bulk Lots: 19G074, 19G075
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14747]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 33
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
D-0528-2022
Recall number D-0528-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 14,566,510 tablets
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
Code information Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14965]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 33
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
D-0529-2022
Recall number D-0529-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 451,123 tablets
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
Code information Product Codes: C135LA Bulk Lots: 19F077
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14293]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 33
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
D-0530-2022
Recall number D-0530-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 14,349,148 tablets
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
Code information Product Codes: C140L Bulk Lots: 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, 19J051
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14067]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 33
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
D-0531-2022
Recall number D-0531-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 3,677,483 tablets
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
Code information Product Codes: L200L Bulk Lots: 18K072, 19C049
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14982]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 33
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
D-0532-2022
Recall number D-0532-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 16,429,211 tablets
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
Code information Product Codes: L202L Bulk Lots: 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, 19H074
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[13955]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 33
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
D-0533-2022
Recall number D-0533-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 3,667,885 tablets
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
Code information Product Codes: L203L Bulk Lots: 18K012, 19E091
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14989]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 33
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
D-0534-2022
Recall number D-0534-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 2,048,941 tablets
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
Code information Product Codes: L206L Bulk Lots: 19B002
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[13951]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 33
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
D-0535-2022
Recall number D-0535-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 6,215,512 tablets
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
Code information Product Codes: L207L Bulk Lots: 18K111, 19E104, 19F050
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14971]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 33
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
D-0536-2022
Recall number D-0536-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 6,249,082 tablets
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
Code information Product Codes: L210L Bulk Lots: 18L120, 19B044, 19E082
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14961]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 33
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
D-0537-2022
Recall number D-0537-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 18,772,640 tablets
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
Code information Product Codes: L211L Bulk Lots: 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, 19F010
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14798]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 33
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
D-0538-2022
Recall number D-0538-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 50,585,623 tablets
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
Code information Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14526]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 33
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
D-0539-2022
Recall number D-0539-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 3,349,387 tablets
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
Code information Product Code: M303 Bulk lots: 19C042, 19C043, 19F083; Product Code: M303A Bulk Lot: 19E105
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14529]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 33
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
D-0540-2022
Recall number D-0540-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 3,052,313 tablets
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
Code information Product Codes: M304 Bulk Lots: 18K059, 18L106, 18L117, 18M067, 18M068
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14053]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 33
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
D-0541-2022
Recall number D-0541-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 3,050,308 tablets
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
Code information Product Codes: M310 Bulk Lots: 19C044, 19H015
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14524]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 33
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
D-0542-2022
Recall number D-0542-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 1,527,203 tablets
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
Code information Product Codes: M311 Bulk Lots: 19A069
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[13965]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 33
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
D-0543-2022
Recall number D-0543-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 5,923,518 tablets
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
Code information Product Codes: M312 Bulk Lots: 18J004, 18J005, 18C045, 19C046
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14769]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 33
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
D-0544-2022
Recall number D-0544-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 7,297,709 tablets
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
Code information Product Codes: M320L Bulk Lots: 18M063, 19G076
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14730]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 33
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
D-0545-2022
Recall number D-0545-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 4,531,580 tablets
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
Code information Product Codes: M333 Bulk Lots: 18M065, 19J078
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14063]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 33
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
D-0546-2022
Recall number D-0546-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 7,983,360 tablets
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
Code information Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[13961]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 33
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
D-0547-2022
Recall number D-0547-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 990,197 tablets
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
Code information Product Codes: M565L Bulk Lots: 19F014
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14719]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 33
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
D-0548-2022
Recall number D-0548-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 6,380,282 tablets
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
Code information Product Codes: M700LA Bulk Lots: 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, 19G046
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14741]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 33
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
D-0549-2022
Recall number D-0549-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 452,038 tablets
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
Code information Product Codes: M701L Bulk Lots: 19G077
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14723]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 33
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
D-0550-2022
Recall number D-0550-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 1,585,375 tablets
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
Code information Product Codes: M710L Bulk Lots: 19A071
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14059]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 33
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
D-0551-2022
Recall number D-0551-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 1,477,641 tablets
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
Code information Product Codes: M740LA Bulk Lots: 19C022, 19C023
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[15034]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 33
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
D-0552-2022
Recall number D-0552-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 14,066,434 tablets
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
Code information Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14050]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 33
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
D-0553-2022
Recall number D-0553-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 25,769,495 tablets
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
Code information Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14765]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 33
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
D-0554-2022
Recall number D-0554-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 8,727,657 tablets
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
Code information Product Codes: M941L M940LA Bulk Lots: 19C065, 19F081, 19H083, 17D088
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[15028]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 33
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
D-0555-2022
Recall number D-0555-2022
Initiated January 26, 2022
Classification Class II
Status Terminated
Quantity 37,464,418 tablets
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
Code information Product Codes: M945 Bulk Lots: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098
Distribution pattern Bulk product was distributed to 3 distributors who may have distributed finished product.
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[14796]
FDA event record
· Exact recall-number query on openFDA
