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.
Resources for You
- Recalls, Market Withdrawals, & Safety Alerts
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Enforcement Reports
- Drug Safety Communications
- Drug Alerts and Statements
- FDA Recall Information on Twitter
- Basic Reset and Biogenyx Recalled Products
Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
---|---|---|---|---|---|---|
Numerous Brands | Various human and animal drug products | As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity cha | Akorn Operating Company LLC | |||
Advil | Over-The-Counter Drugs | Product was stored outside of labeled temperature requirements. | Family Dollar | |||
Mayne Pharma Inc. | FENTANYL Buccal Tablets CII | Safety updates were omitted in the Product Insert/Medication Guide (MG) | Teva Pharmaceuticals USA | |||
Pro Power Knight Plus, NUX, Dynamite Super | Male enhancement capsules | Product contains undeclared tadalafil and sildenafil | Gadget Island, Inc. | |||
Camber | Atovaquone Oral Suspension | Potential Bacillus cereus Contamination | Camber Pharmaceuticals, Inc. | |||
Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution | Due to Presence of Methanol | Jarman’s Midwest Cleaning Systems, Inc. | |||
Ascend Laboratories | Dabigatran Etexilate Capsules, USP | Detection of N-nitroso-dabigatran (NDAB) 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 |