American Regent, Inc. has announced a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multiple-dose vials in the United States. The recall, announced on September 3, 2026, was initiated after complaints involving leaking and cracked vials raised concerns about the sterility of the affected products.
The company’s investigation also identified particulate matter in the recalled product. The particles were identified as nylon, cellulosic material, acrylic, polyethylene and glass. According to the recall notice, the combination of particulate contamination and compromised vial integrity creates potential risks for patients receiving the affected product.
The recalled epinephrine injection is supplied as a clear, colorless, sterile solution containing 1 mg/mL of epinephrine in a 30 mL multiple-dose vial. The product may be administered intravenously, intramuscularly or subcutaneously under the direction of a healthcare professional. It is indicated for the emergency treatment of Type I allergic reactions, including anaphylaxis, and is also indicated to increase mean arterial blood pressure in adults with hypotension associated with septic shock.
The affected product carries NDC 0517-3030-01. The three recalled lot numbers are 25128L1C0, 25280L1C0 and 26108L1C0. Lot 25128L1C0 has an expiration date of August 2026 and was distributed from September 4, 2025, through December 18, 2025. Lot 25280L1C0 expires in October 2026 and was distributed from December 16, 2025, through April 17, 2026. Lot 26108L1C0 expires in July 2027 and was distributed from June 15, 2026, through July 31, 2026. All three lots were distributed nationwide in the United States.
American Regent stated that intravenous administration of epinephrine containing particulate matter may result in serious health consequences. Particles entering the bloodstream can potentially cause vascular blockage or clotting, which may interfere with blood flow to vital organs. The recall notice also warns of the possibility of pulmonary embolism, permanent organ damage or death, as well as local vein irritation, inflammatory reactions and allergic reactions.
The cracked or leaking vials present an additional concern because damage to the container can compromise product integrity and result in loss of sterility or contamination. American Regent said that, as of the recall announcement, it had not received reports of adverse events associated with the recalled products.
Distributors, retailers and healthcare facilities that have any of the affected lots are instructed to stop using the products and return them to the place of purchase or discard them. American Regent is notifying distributors and customers and is arranging for the return, replacement and credit of recalled products.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Patients and healthcare professionals who have questions about the recall are advised to contact American Regent or their healthcare provider.
