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 |
---|---|---|---|---|---|---|
Brexafemme | Antifungal oral medication | Potential cross contamination with non-antibacterial beta-lactam drug substance | Scynexis, Inc. | |||
VistaPharm | Sucralfate Oral Suspension 1g/10mL | Potential contamination with Bacillus cereus | Potential contamination with Bacillus cereus | |||
Novartis | Sandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mL | Crystal formation which could potentially result in incorrect dosing | Novartis Pharmaceuticals Corporation | |||
TheraBreath | TheraBreath Kids Strawberry Splash Oral Rinse | Device & Drug Safety/Microbial Contamination | Church & Dwight Co., Inc. | |||
WEFUN | Dietary Supplement with undeclared Sildenafil | Undeclared drug, Sildenafil | Hua Da Trading Inc dba Wefun Inc | |||
Marlex Pharmaceuticals, Inc. | Digoxin Tablets USP, 0.125mg and 0.25mg | Label Mix-Up | Marlex Pharmaceuticals, Inc. | |||
Dr. Berne’s | MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5% Solution | Bacterial and Fungal Contamination | Dr. Berne’s Whole Health Products | |||
Numerous brand names | Numerous human food, animal (pet) food, medical devices, and drug products | Potential Salmonella contamination and presence of rodent activity at the distribution center & temperature abuse | Inmar Supply Chain Solutions | |||
Lupin Pharmaceuticals, Inc. | Tydemy oral contraceptive | Out of Specification Results | Lupin Pharmaceuticals, Inc. | |||
Cipla | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) | Failure to deliver the recommended dose | Cipla |