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 to remove a defective drug product from the market or warn patients and consumers about a potential risk.
The list below includes voluntary drug recalls in which public notification has been issued.
Visit FDA’s role in drug recalls for more information.
Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
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Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
---|---|---|---|---|---|---|
Sagent | Docetaxel Injection, USP | Potential presence of particulate matter | Sagent Pharmaceuticals | |||
Hospira | Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units | Device & Drug Safety – Potential Packaging Defect | Hospira Inc. | |||
Schwinnng | Herbal Dietary Supplement | Product is tainted with Nortadalafil | STOP CLOPEZ CORP | |||
Dr. Reddy’s | Sapropterin Dihydrochloride Powder for Oral Solution 100 mg | Decreased Potency | Dr. Reddy’s Laboratories Inc | |||
Fendall 2000 | Non-Sterile Eyewash Cartridge | Non-compliance with current good manufacturing practice (cGMP) requirements. | Honeywell Safety Products USA | |||
Aruba Aloe | Hand Sanitizer Gel and Alcoholada Gel | Product contains methanol | Aruba Aloe Balm N.V. | |||
ForeverMen | Natural Energy Boost | Product is tainted with sildenafil and tadalafil | FAonline Inc | |||
AVpak | Atovaquone Oral Suspension, USP 750mg/5mL | Potential Bacillus cereus contamination | AvKARE, LLC | |||
Eugia US LLC | Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) | Device & Drug Safety – Presence of Particulate Matter | Eugia US LLC | |||
Amneal | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL | Super potent due to bottles being overfilled | Amneal Pharmaceuticals, LLC. |