American Regent Recalls Epinephrine Injection Vials Due to Particulate Matter and Cracks

American Regent, Inc. is conducting a nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multidose vials. The recall, initially announced by the FDA on September 3, 2026, follows customer complaints of leaking and cracked vials, and the detection of particulate matter, including nylon, cellulosic, acrylic, polyethylene, and glass particles, during the company's investigation. Intravenous administration of the affected product could lead to serious adverse health consequences due to a lack of assurance of sterility. The recall extends to the consumer level.