FDA Orders Nationwide Recall of American Regent Epinephrine Vials Over Sterility and Contamination Risks
The FDA has issued a nationwide voluntary recall for three lots of American Regent’s epinephrine injections due to cracked vials and particulate contamination. The affected multi-dose vials, used for emergency allergic reactions, were distributed across the U.S. between September 2025 and July 2026. No adverse events have been reported, but patients are urged to stop using the product and contact their providers.