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 401–420 of 17,529 recalls

August 13, 2025· Sandoz Inc

Recalled Item: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only

The Issue: Temperature Abuse

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

Class II — Potential Health HazardOngoing
Refund
August 12, 2025· VIONA PHARMACEUTICALS INC

Recalled Item: Tavaborole Topical Solution 5%

The Issue: Discoloration

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

Class II — Potential Health HazardOngoing
Refund
August 11, 2025· Lannett Company Inc.

Recalled Item: Lisdexamfetamine Dimesylate Capsules

The Issue: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine

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

Class II — Potential Health HazardCompleted
Refund
August 8, 2025· Breckenridge Pharmaceutical, Inc.

Recalled Item: Duloxetine Delayed-Release Capsules

The Issue: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim

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

Class II — Potential Health HazardOngoing
Refund
August 8, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Theophylline extended-release tablets 400mg

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
August 7, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Carvedilol Tablets

The Issue: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol

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

Class II — Potential Health HazardOngoing
Refund
August 7, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Carvedilol Tablets

The Issue: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol

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

Class II — Potential Health HazardOngoing
Refund
August 7, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Carvedilol Tablets

The Issue: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol

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

Class II — Potential Health HazardOngoing
Refund
August 6, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Carvedilol Tablets

The Issue: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI)

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

Class II — Potential Health HazardOngoing
Refund
August 6, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Carvedilol Tablets

The Issue: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI)

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

Class II — Potential Health HazardOngoing
Refund
August 6, 2025· Westminster Pharmaceuticals LLC

Recalled Item: Metoprolol Tartrate Tablets

The Issue: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above

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

Class II — Potential Health HazardOngoing
Refund
August 6, 2025· Westminster Pharmaceuticals LLC

Recalled Item: Metoprolol Tartrate Tablets

The Issue: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above

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

Class II — Potential Health HazardOngoing
Refund
August 5, 2025· Cardinal Health Inc.

Recalled Item: Enoxaparin Sodium Injection

The Issue: Correct Labeled Product Mispack: Bags labeled for Enoxaparin

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

Class II — Potential Health HazardOngoing
Refund
August 5, 2025· Haleon US Holdings LLC

Recalled Item: Sensodyne PRONAMEL (Potassium nitrate 5%

The Issue: Labeling: Label Mix-up: The outer carton is labelled

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

Class III — Low RiskOngoing
Refund
August 5, 2025· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Spironolactone Tablets

The Issue: Presence of foreign substance: identified as aluminum

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

Class II — Potential Health HazardOngoing
Refund
August 4, 2025· PFIZER INC

Recalled Item: Vial Label: 8.4% Sodium Bicarbonate Injection

The Issue: Sterility Concerns

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

Class II — Potential Health HazardOngoing
Refund
August 4, 2025· PFIZER INC

Recalled Item: Vial Label: Epinephrine Injection

The Issue: Sterility Concerns

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

Class II — Potential Health HazardOngoing
Refund
August 4, 2025· B BRAUN MEDICAL INC

Recalled Item: 0.9% Sodium Chloride Injection USP

The Issue: Lack of Assurance of Sterility; potential for fluid

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

Class II — Potential Health HazardOngoing
Refund
August 4, 2025· B BRAUN MEDICAL INC

Recalled Item: Lactated Ringer's Injection USP

The Issue: Lack of Assurance of Sterility; potential for fluid

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

Class II — Potential Health HazardOngoing
Refund
July 30, 2025· GenoGenix LLC

Recalled Item: Reconstitution XO Solution for Injection

The Issue: Sterility Concerns

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

Class II — Potential Health HazardOngoing
Refund