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 201–220 of 17,529 recalls

October 28, 2025· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Lisdexamfetamine Dimesylate Capsules

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
October 28, 2025· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Lisdexamfetamine Dimesylate Capsules

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
October 28, 2025· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Lisdexamfetamine Dimesylate Capsules

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
October 28, 2025· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Lisdexamfetamine Dimesylate Capsules

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
October 27, 2025· Otsuka ICU Medical LLC

Recalled Item: 0.9% SODIUM CHLORIDE Injection

The Issue: Lack of Assurance of Sterility: Potential for flexible

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

Class II — Potential Health HazardOngoing
Refund
October 24, 2025· Cipla USA, Inc.

Recalled Item: Lanthanum Carbonate chewable tablets

The Issue: Failed stability specifications: Out of specification for hardness

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

Class II — Potential Health HazardOngoing
Refund
October 24, 2025· Cipla USA, Inc.

Recalled Item: Lanthanum Carbonate chewable tablets

The Issue: Failed stability specifications: Out of specification for hardness

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

Class II — Potential Health HazardOngoing
Refund
October 23, 2025· Zydus Pharmaceuticals (USA) Inc

Recalled Item: Bromocriptine Mesylate Capsules

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
October 22, 2025· Zydus Pharmaceuticals (USA) Inc

Recalled Item: clomiPRAMINE Hydrochloride

The Issue: cGMP deviations: an observed Out of Specification of

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

Class II — Potential Health HazardOngoing
Refund
October 22, 2025· Zydus Pharmaceuticals (USA) Inc

Recalled Item: clomiPRAMINE Hydrochloride

The Issue: cGMP deviations: an observed Out of Specification of

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

Class II — Potential Health HazardOngoing
Refund
October 22, 2025· Zydus Pharmaceuticals (USA) Inc

Recalled Item: clomiPRAMINE Hydrochloride

The Issue: cGMP deviations: an observed Out of Specification of

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

Class II — Potential Health HazardOngoing
Refund
October 21, 2025· Kenvue Brands LLC

Recalled Item: TYLENOL

The Issue: Defective Container

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

Class II — Potential Health HazardOngoing
Refund
October 21, 2025· Bristol-Myers Squibb Company

Recalled Item: Opdualag (nivolumab and relatlimab-rmbw) injection

The Issue: Sterility Concerns

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

Class II — Potential Health HazardOngoing
Refund
October 20, 2025· ANTHONY TRINH, 123Herbals LLC

Recalled Item: SILINTAN 25/pills

The Issue: Undeclared Meloxicam

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

Class I — Serious Health HazardOngoing
Refund
October 20, 2025· Golden State Medical Supply Inc.

Recalled Item: NIACIN Extended-Release Tablets

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
October 20, 2025· Imprimis NJOF, LLC

Recalled Item: Klarity-C Drops (Cyclosporine) 0.1%

The Issue: Subpotent Drug

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

Class III — Low RiskOngoing
Refund
October 17, 2025· Aero Healthcare

Recalled Item: Acetaminophen 500mg Caffeine 65mg caplets

The Issue: Labeling: Label Mix-up. This issue affects the outer

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

Class II — Potential Health HazardOngoing
Refund
October 16, 2025· Amerisource Health Services LLC

Recalled Item: Prazosin Hydrochloride

The Issue: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impu

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

Class II — Potential Health HazardOngoing
Refund
October 16, 2025· Amerisource Health Services LLC

Recalled Item: Prazosin Hydrochloride

The Issue: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impu

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

Class II — Potential Health HazardOngoing
Refund
October 16, 2025· Amerisource Health Services LLC

Recalled Item: Prazosin Hydrochloride

The Issue: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impu

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

Class II — Potential Health HazardOngoing
Refund