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 161–180 of 17,529 recalls

November 20, 2025· Fagron Compounding Services

Recalled Item: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical...

The Issue: Incorrect Product Formulation

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

Class II — Potential Health HazardOngoing
Refund
November 18, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Nebivolol Tablets

The Issue: Cross Contamination with Other Products

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

Class III — Low RiskOngoing
Refund
November 17, 2025· Preferred Pharmaceuticals, Inc.

Recalled Item: Ondansetron ODT Tablets

The Issue: Defective container: Preferred Pharmaceuticals received a letter from

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

Class II — Potential Health HazardOngoing
Refund
November 14, 2025· Cipla USA, Inc.

Recalled Item: Cinacalcet Hydrochloride Tablets

The Issue: CGMP Deviations: the presence of a nitrosamine impurity,

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

Class II — Potential Health HazardOngoing
Refund
November 14, 2025· Cipla USA, Inc.

Recalled Item: Cinacalcet Hydrochloride Tablets

The Issue: CGMP Deviations: the presence of a nitrosamine impurity,

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

Class II — Potential Health HazardOngoing
Refund
November 14, 2025· Cipla USA, Inc.

Recalled Item: Cinacalcet Hydrochloride Tablets

The Issue: CGMP Deviations: the presence of a nitrosamine impurity,

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

Class II — Potential Health HazardOngoing
Refund
November 13, 2025· Lupin Pharmaceuticals Inc.

Recalled Item: Ganirelix Acetate Injection

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardOngoing
Refund
November 12, 2025· Medical Products Laboratories, Inc.

Recalled Item: Walgreens Saline Nasal Spray WITH XYLITOL

The Issue: Microbial contamination of a non-sterile product - microorganism

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

Class II — Potential Health HazardOngoing
Refund
November 11, 2025· Dr. Reddy's Laboratories, Inc.

Recalled Item: Varenicline Tablets

The Issue: Sub potent drug: during the 9-month stability test

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

Class III — Low RiskOngoing
Refund
November 7, 2025· Teva Pharmaceuticals USA, Inc

Recalled Item: Carton label: Testosterone Gel 1%

The Issue: Defective Container - A defect in the side-seal

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

Class III — Low RiskOngoing
Refund
November 6, 2025· Fresenius Kabi USA, LLC

Recalled Item: Famotidine Injection

The Issue: Microbial Contamination of Sterile Products; out of limit

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

Class I — Serious Health HazardOngoing
Refund
November 5, 2025· Lupin Pharmaceuticals Inc.

Recalled Item: Sertraline Hydrochloride Tablets USP

The Issue: Defective container - seal not adhering to bottles

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: Benco dental Graham CHEMICAL CO.

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: darby dental supply

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: 3% Polocaine DENTAL

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: 2% Xylocaine DENTAL with Epinephrine 1:100

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: OraVerse

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: Cook-Walte

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Novocol Pharmaceutical of Canada, Inc.

Recalled Item: Lidocaine HCI 2% and Epinephrine 1:100

The Issue: Defective container: cracked/broken cartridges

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

Class II — Potential Health HazardOngoing
Refund
October 31, 2025· Blossom Pharmaceuticals

Recalled Item: Wecare Calasoothe

The Issue: cGMP deviations

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

Class II — Potential Health HazardOngoing
Refund