Ohio-based American Regent Inc. has issued a nationwide recall for three lots of its Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials. The recall is prompted by concerns over sterility and the potential presence of foreign particulate matter within the medication. Epinephrine is a critical drug used for the emergency treatment of life-threatening allergic reactions, such as anaphylaxis, and can also be administered to increase blood pressure in patients with septic shock.
The company initiated the recall after receiving consumer complaints detailing leaking and cracked vials, which raised doubts about the product's sterility. Subsequent investigation by American Regent Inc. identified particulate matter, including nylon, cellulose, acrylic, polyethylene, and glass, within the affected vials. The U.S. Food and Drug Administration (FDA) has warned that administering epinephrine injections containing particulate matter intravenously could lead to severe adverse health consequences.
According to the FDA, such particles can obstruct and cause clotting in blood vessels, potentially leading to a cessation of blood flow to vital organs, a life-threatening pulmonary embolism, permanent organ damage, or death. The particles may also induce local vein irritation, inflammatory reactions, aggravate existing infections, and trigger allergic responses. Cracked vials, in turn, can compromise the container's integrity, leading to a loss of sterility and potential contamination.
The recalled lot numbers are 25128L1C0, 25280L1C0, and 26108L1C0. These lots, distributed nationwide, have expiration dates of August 2026, October 2026, and July 2027. Distribution to patients occurred between September 2025 and July 2026.
To date, no adverse events have been reported in connection with this recall. In the United States, anaphylaxis affects an estimated 3.4 million to 17 million individuals annually, resulting in approximately 225 deaths. Sepsis impacts about 1.7 million adults each year, with at least 350,000 fatalities.
