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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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Showing 4,381–4,400 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03

by Ultra Seal Corporation

Reason
cGMP deviations
Recall initiated
January 24, 2022
Reported by FDA
February 9, 2022
Distribution
Nationwide within the United States

View recall →

Data last updated:

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.