The Food and Drug Administration announced Thursday that American Regent is voluntarily recalling three lots of epinephrine injection vials distributed nationwide, after customers reported leaking and cracked vials that raised doubts about sterility.
What was found
The recalled product is epinephrine injection USP 30 mg/30 mL (1 mg/mL), sold as a multi-dose vial. American Regent said its own investigation found particulate matter in the vials, including nylon, cellulose, acrylic, polyethylene and glass. Because the vials leaked and cracked, the company said it could not assure the sterility of the medicine inside.
Which lots are affected
The three recalled lots are 25128L1C0, distributed from September 2025 to December 2025 and expiring in August 2026; 25280L1C0, distributed from December 2025 to April 2026 and expiring in October 2026; and 26108L1C0, distributed from June 2026 to July 2026 and expiring in July 2027. The vials carry the NDC number 0517-3030-01. The FDA lists the action as a Class II recall, meaning use of the product could cause temporary or medically reversible health problems.
Why epinephrine matters
Epinephrine is the first-line treatment for anaphylaxis, the fast and dangerous allergic reaction that can follow insect stings, foods or drugs. It is also used in emergency care for cardiac arrest. Contaminated or non-sterile vials could introduce infection or fail to work when a patient's life depends on it. American Regent said it has not received any reports of adverse events linked to the recalled lots. The company is notifying distributors and customers and arranging returns and replacements. Pharmacies and patients who have affected vials should stop using them and contact American Regent at 800-645-1706 during business hours.