American Regent recalls epinephrine injections over cracked vials

American Regent announced a voluntary nationwide recall on Thursday covering three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials, citing customer complaints about vials that leaked or cracked and could no longer be guaranteed sterile.

Testing conducted during the company's investigation turned up particulate matter inside the vials, with identified materials including nylon, cellulosic, acrylic, polyethylene, and glass, the company said. When injected intravenously, such particles put patients at risk for vascular blockages, loss of blood flow to critical organs, fatal pulmonary embolism, irreversible organ damage, or death, the company warned. Vials that are cracked create an opening for contamination that would not be present in an intact container, introducing a separate hazard for patients, the company said.

The recall covers lot numbers 25128L1C0, 25280L1C0, and 26108L1C0, all distributed under NDC number 0517-3030-01. The lots were distributed at different points between September 2025 and July 2026. American Regent said it has not received any reports of adverse events related to the recall.

Epinephrine injections are used for the emergency treatment of severe allergic reactions, including anaphylaxis triggered by insect stings, foods, or drugs, and to increase blood pressure in adult patients with hypotension associated with septic shock, the company said.

American Regent has begun contacting distributors and customers directly to coordinate the return or replacement of every unit covered by the recall. Distributors, retailers, and healthcare facilities that have the recalled product should stop using it and return it to the place of purchase or discard it. Patients should stop using the product and contact their doctor or healthcare provider.

Consumers and healthcare professionals with questions can contact American Regent customer service at 800-645-1706. Adverse events can be reported to the company's pharmacovigilance team at 800-734-9236 or pv@americanregent.com , or to the FDA's MedWatch program at 1-800-332-1088. The recall is being conducted with the knowledge of the FDA.