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 |
---|---|---|---|---|---|---|
LEADER | OTC Ophthalmic Sterile Drops | Insanitary manufacturing conditions | Cardinal Health, Inc. | |||
Rugby | OTC Ophthalmic Sterile Drops | Insanitary manufacturing conditions | The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories | |||
Exela and Civica Brands | Sodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection ELCYS (cysteine hydrochloride Injection), USP | Potential presence of particulate matter | Exela Pharma Sciences, LLC | |||
Multiple brands | Dietary Supplements with undeclared Diclofenac | Undeclared drug, Diclofenac | Botanical-Be | |||
Multiple brands | Over-the-Counter Drug and Medical Device products | Products were stored outside of labeled temperature requirements | Family Dollar | |||
KVK Tech | Betaxolol Tablets, USP | Potential Presence of Oxycodone HCl tablet | KVK-Tech, Inc. | |||
Hospira | 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP | Potential Presence of Glass Particulates | Hospira, Inc. | |||
Ion and Restore brands | Nasal Sprays | Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp. | Biomic Sciences | |||
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 |