American Regent Recalls Epinephrine Injection Vials Over Particles and Sterility Concerns

American Regent is recalling three lots of Epinephrine Injection, USP 30 mg/30 mL multidose vials after cracked and leaking containers and particulate matter raised sterility and safety concerns. Steve Heap/Shutterstock

American Regent is recalling three lots of Epinephrine Injection, USP after complaints involving cracked and leaking vials and an investigation that found particulate matter in the medication.

The voluntary nationwide recall applies to Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multidose vials and extends to the consumer level. The company announced the recall September 3, 2026, according to a notice posted by the U.S. Food and Drug Administration.