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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

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

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Drug Recall Terminated Historical recordClass II

Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Drug Recall Terminated Historical recordClass II

APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Drug Recall Terminated Historical recordClass II

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

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

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Drug Recall Terminated Historical recordClass II

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

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Drug Recall Terminated Historical recordClass II

Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Drug Recall Terminated Historical recordClass II

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

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Drug Recall Terminated Historical recordClass II

3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00

by ULTRAtab Laboratories, Inc.

Reason: CGMP Deviations
Recall initiated: January 26, 2022
Reported by FDA: February 16, 2022
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.

View recall →

Data last updated: September 13, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.