American Regent, Inc has initiated a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL), packaged in multidose glass vials. The recall began after customer complaints reported cracked and leaking containers, potentially compromising sterility. A subsequent company investigation also identified foreign particulate matter in the affected product, including nylon, cellulosic material, acrylic, polyethylene, and glass.
Importantly, the recall applies specifically to American Regent’s 30 mL multidose injectable vials of epinephrine for food allergies and other causes of anaphylaxis. It does not involve epinephrine auto-injectors or nasal sprays. The recalled product is administered intravenously, intramuscularly, or subcutaneously and is intended for use by, or under the direction of, a physician.
The potential health consequences of compromised vials can be serious, especially if particulate matter is administered intravenously. According to the company’s risk assessment, injecting 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.” Foreign particles can also cause localized vein irritation, allergic reactions, or inflammatory responses. Cracked vials can compromise sterility and potentially expose patients to contamination.
The medication is indicated for the emergency treatment of Type I allergic reactions, including anaphylaxis caused by foods, drugs, insect stings and bites, and other allergens. It is also indicated to increase mean arterial blood pressure in adults with hypotension associated with septic shock. Despite the potentially serious consequences of the defects, American Regent stated that “to date, American Regent has not received any reports of adverse events related to this recall.”
The recall involves NDC 0517-3030-01 and three lots distributed nationwide: Lot 25128L1C0, with an expiration date of August 2026; Lot 25280L1C0, expiring October 2026; and Lot 26108L1C0, expiring July 2027. The affected lots were distributed between September 2025 and July 2026.
American Regent is notifying distributors and customers by letter and arranging for the return and replacement of recalled products. Distributors, retailers, healthcare facilities, and patients with the affected product have been instructed to immediately stop using it and either return it to the place of purchase or dispose of it appropriately.
Healthcare professionals and others with questions regarding returns or replacements can contact American Regent Customer Service at 1-800-645-1706. Product quality complaints and medical questions can be directed to the company at 1-888-354-4855. Adverse reactions or quality problems associated with the recalled product can also be reported to the FDA’s MedWatch Adverse Event Reporting program.
