New Albany, Ohio – September 08, 2026 -- American Regent, Inc. is voluntarily recalling three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi dose vials nationwide, down to the consumer level.
Customers reported leaking and cracked vials
The recall follows customer complaints of leaking and cracked vials, which compromise sterility assurance. The company's investigation also found particulate matter identified as nylon, cellulosic material, acrylic, polyethylene and glass inside affected vials.
Contaminated injections can cause blood clots and organ damage
Intravenous administration of contaminated product may cause blockages and clotting in blood vessels, cutting off blood flow to vital organs. This can lead to a life-threatening pulmonary embolism, permanent organ damage, or death. The particles may also trigger local vein irritation, inflammatory reactions, worsened existing infections, or allergic reactions. Cracked vials additionally risk loss of sterility and contamination.
No adverse events reported so far
American Regent said it has not received any reports of adverse events tied to this recall as of the announcement.
Three lots distributed across the United States
The affected lots -- numbered 25128L1C0, 25280L1C0, and 26108L1C0 -- were distributed nationwide in the United States. The drug is used for emergency treatment of severe allergic reactions, including anaphylaxis from insect stings, foods, drugs, or other allergens, and to raise blood pressure in adults with septic shock-related hypotension.
Company is arranging returns and replacements
American Regent is notifying distributors and customers by letter and arranging for return or replacement of all recalled product. Distributors, retailers, and healthcare facilities holding the recalled lots should stop using them and return the product to its point of purchase, or discard it.
Patients using the affected product should stop and contact their doctor or healthcare provider. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.