American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility. The firm’s investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass.
Risk Statement: Intravenous administration of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) containing particulate matter may lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Additionally, cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients. To date, American Regent has not received any reports of adverse events related to this recall.