Drug Recalls

Here you'll find every drug recall the FDA has issued, including prescription medications, over-the-counter drugs, compounded pharmacy products, and dietary supplements. We've been tracking these since 2006 and our database updates several times a day so you're always looking at current information.

Drugs get recalled for a number of reasons: contamination during manufacturing, incorrect potency or dosage, failed quality testing (like dissolution or stability tests), sterility problems in injectable products, or labeling and packaging errors that could cause someone to take the wrong dose. If you find a product on this list that you use, please follow the instructions provided by the FDA to take the necessary precautions.

17,529 total recalls
2 this month

Showing 901–920 of 17,529 recalls

December 12, 2024· Ascend Laboratories, LLC

Recalled Item: Dabigatran Etexilate

The Issue: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 11, 2024· Glenmark Pharmaceuticals Inc., USA

Recalled Item: chlorproMAZINE Hydrochloride Tablets

The Issue: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 11, 2024· Glenmark Pharmaceuticals Inc., USA

Recalled Item: chlorproMAZINE Hydrochloride Tablets

The Issue: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 10, 2024· VIONA PHARMACEUTICALS INC

Recalled Item: Dapsone Gel 7.5%

The Issue: Crystallization

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 10, 2024· VIONA PHARMACEUTICALS INC

Recalled Item: Dapsone Gel 7.5%

The Issue: Crystallization

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 10, 2024· Regenerative Processing Plant, LLC

Recalled Item: LITE Regener-Eyes

The Issue: Lack of Sterility Assurance

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 10, 2024· Regenerative Processing Plant, LLC

Recalled Item: PROFESSIONAL Regener-Eyes

The Issue: Lack of Sterility Assurance

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 6, 2024· Breckenridge Pharmaceutical, Inc

Recalled Item: Duloxetine Delayed-Release Capsules

The Issue: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 6, 2024· Amerisource Health Services LLC

Recalled Item: Duloxetine Delayed-Release Capsules

The Issue: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 6, 2024· Amerisource Health Services LLC

Recalled Item: Duloxetine Delayed-Release Capsules USP

The Issue: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 6, 2024· Amerisource Health Services LLC

Recalled Item: Duloxetine Delayed-Release Capsules USP

The Issue: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 6, 2024· Breckenridge Pharmaceutical, Inc

Recalled Item: Duloxetine Delayed-Release Capsules

The Issue: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 6, 2024· Amerisource Health Services LLC

Recalled Item: Duloxetine Delayed-Release Capsules

The Issue: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 6, 2024· Aurobindo Pharma USA Inc

Recalled Item: Nebivolol Tablets

The Issue: CGMP Deviations: Presence of Nitrosamine Drug Substance Related

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 5, 2024· FDC Limited

Recalled Item: Timolol Maleate Ophthalmic Solution USP

The Issue: Defective Container: Unable to get the solution out

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 4, 2024· AvKARE

Recalled Item: Nitrofurantoin Capsules

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 4, 2024· PD-Rx Pharmaceuticals, Inc.

Recalled Item: DULoxetine DR USP

The Issue: CGMP Deviations: the presence of a Nitrosamine Drug

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 2, 2024· RemedyRepack Inc.

Recalled Item: Duloxetine Delayed-Release Capsules

The Issue: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
November 27, 2024· AvKARE

Recalled Item: Cinacalcet Tablets

The Issue: CGMP deviations: Presence of Nitrosamine Drug Substance Related

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
November 27, 2024· AvKARE

Recalled Item: Cinacalcet Tablets

The Issue: CGMP deviations: Presence of Nitrosamine Drug Substance Related

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund