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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 4,361–4,380 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42

by Teva Pharmaceuticals USA

Reason
Mislabeling
Recall initiated
January 7, 2022
Reported by FDA
February 9, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28

by Teva Pharmaceuticals USA

Reason
Mislabeling
Recall initiated
January 7, 2022
Reported by FDA
February 9, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Recall initiated
January 10, 2022
Reported by FDA
February 9, 2022
Distribution
nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sinus Relief Headache/Nasal (acetaminophen 325mg, 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

Sinus Relief (acetaminophen 325mg, 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

REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 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

REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 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

ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 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

MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 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

SINUS DECONGESTANT Nasal Decongestant (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

AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) 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 Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 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

CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated 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

FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) 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

Nutralox Mint Antacid (calcium carbonate 420mg) Chewable 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

Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet 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

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6

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

CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895

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, 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 350mg) 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 →

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.