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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 4,401–4,420 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832

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

Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, 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

Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

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

Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487

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

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

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

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

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

Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00

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

MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA

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

Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02

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

Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24

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

DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46270

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

Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40

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

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50

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 (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.

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

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2

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

Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68

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

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

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 Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 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

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, 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 Ongoing Historical recordClass II

Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083

by Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
December 21, 2021
Reported by FDA
February 9, 2022
Distribution
nationwide in the USA

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.