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
1 this month

Showing 5581–5600 of 17,529 recalls

June 12, 2020· Aurobindo Pharma USA Inc.

Recalled Item: Clozapine Tablets USP tablet

The Issue: Presence of foreign tablet: Consumer complaint of Clozapine

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

Class II — Potential Health HazardTerminated
Refund
June 11, 2020· Lupin Pharmaceuticals Inc.

Recalled Item: Metformin Hydrochloride Extended-release Tablets USP

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity

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

Class II — Potential Health HazardTerminated
Refund
June 11, 2020· Hikma Pharmaceuticals USA Inc.

Recalled Item: Irinotecan HCL Injection

The Issue: Defective Container: Customer complaints received of a crimp

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

Class II — Potential Health HazardTerminated
Refund
June 11, 2020· Hikma Pharmaceuticals USA Inc.

Recalled Item: Irinotecan HCL Injection

The Issue: Defective Container: Customer complaints received of a crimp

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

Class II — Potential Health HazardTerminated
Refund
June 10, 2020· American Health Packaging

Recalled Item: Nabumetone Tablets

The Issue: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense

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

Class III — Low RiskTerminated
Refund
June 10, 2020· Crown Laboratories

Recalled Item: Nystatin Cream

The Issue: Subpotent Drug: Out of specification for assay at

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

Class II — Potential Health HazardTerminated
Refund
June 10, 2020· Alembic Pharmaceuticals Limited

Recalled Item: Aripiprazole Tablets

The Issue: Labeling: Label mix up: Bottles labeled as aripiprazole

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

Class II — Potential Health HazardTerminated
Refund
June 10, 2020· Crown Laboratories

Recalled Item: Nystatin Cream

The Issue: Subpotent Drug: Out of specification for assay at

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

Class II — Potential Health HazardTerminated
Refund
June 9, 2020· MasterPharm LLC

Recalled Item: Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule

The Issue: Super-potent Drug: This recall has been initiated due

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

Class I — Serious Health HazardTerminated
Refund
June 5, 2020· Marksans Pharma Limited

Recalled Item: Time-Cap Labs

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity

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

Class II — Potential Health HazardTerminated
Refund
June 5, 2020· PD-Rx Pharmaceuticals, Inc.

Recalled Item: metFORMIN HCL ER 500 mg

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity

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

Class II — Potential Health HazardTerminated
Refund
June 5, 2020· PD-Rx Pharmaceuticals, Inc.

Recalled Item: metFORMIN HCL ER USP 500 mg

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity

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

Class II — Potential Health HazardTerminated
Refund
June 5, 2020· Akorn, Inc.

Recalled Item: Prednisolone Sodium Phosphate Oral Solution

The Issue: Discoloration: Out of Specification (OOS) result for APHA

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

Class III — Low RiskTerminated
Refund
June 4, 2020· SOMERSET THERAPEUTICS LLC

Recalled Item: Brimonidine Tartrate Opthalmic Solution 0.2%

The Issue: Failed Impurities/Degradation Specification: There is a slow leaching

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

Class III — Low RiskTerminated
Refund
June 4, 2020· SOMERSET THERAPEUTICS LLC

Recalled Item: Brimonidine Tartrate Opthalmic Solution 0.2%

The Issue: Failed Impurities/Degradation Specification: There is a slow leaching

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

Class III — Low RiskTerminated
Refund
June 4, 2020· SOMERSET THERAPEUTICS LLC

Recalled Item: Brimonidine Tartrate Opthalmic Solution 0.2%

The Issue: Failed Impurities/Degradation Specification: There is a slow leaching

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

Class III — Low RiskTerminated
Refund
June 4, 2020· AVKARE Inc.

Recalled Item: Metformin Hydrochloride Extended-Release Tablets

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity

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

Class II — Potential Health HazardTerminated
Refund
June 4, 2020· AVKARE Inc.

Recalled Item: Metformin Hydrochloride Extended-Release Tablets

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity

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

Class II — Potential Health HazardTerminated
Refund
June 3, 2020· Yusef Manufacturing Laboratories, LLC

Recalled Item: Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%

The Issue: Superpotent Drug: Active Ingredient Octisalate found at 15%

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

Class II — Potential Health HazardTerminated
Refund
June 3, 2020· WALKER EMULSIONS INC

Recalled Item: Walker Emulsions Hand Sanitizer (60%)

The Issue: Undeclared Excipients

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

Class II — Potential Health HazardTerminated
Refund