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  1. Drug Safety and Availability

Drug Recalls

A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.

The list below includes voluntary recalls in which public notification has been issued.

See FDA’s role in drug recalls for more information.
See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
For recall notices older than 60 days, see recall and safety alerts archive.

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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall Excerpt
Ascend Laboratories Dabigatran Etexilate Capsules, USP Detection of N-Nitrosodimethylamine (NDMA) Impurity Ascend Laboratories LLC.
Purely Soothing 15% MSM Drops Non-sterility Pharmedica USA LLC
Apotex Brimonidine Tartrate Ophthalmic Solution, 0.15% Potential lack of sterility. Apotex Corp.
Delsam Pharma’s Artificial Eye Ointment Due to possible microbial contamination Global Pharma Healthcare
nanoMaterials Discovery Corporation Hand Sanitizer Due to presence of methanol nanoMaterials Discovery Corporation
PrimeZEN PrimeZEN Black 6000 male enhancement capsules Product contains undeclared tadalafil and sildenafil Volt Candy
EzriCare & Delsam Pharma Artificial Tears Lubricant Eye Drops Potential microbial contamination Global Pharma Healthcare
IBSA TIROSINT®-SOL (levothyroxine sodium) Subpotency IBSA Pharma Inc.
Banana Boat Hair & Scalp Spray SPF 30 Due to presence of benzene Edgewell Personal Care
Spectrum Epinephrine bulk API Product discoloration Spectrum Laboratory Products Inc.
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