American Regent recalls Epinephrine Injection due to particulate matter and sterility concerns
News provided byAmerican Regent, Inc · 1 min read
NEW ALBANY, Ohio, Sept. 3, 2026 /CourierPR/ -- American Regent, Inc. has initiated a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) due to the presence of particulate matter and concerns over sterility. The company identified nylon, cellulosic, acrylic, polyethylene, and glass particles in the vials, raising significant health risks.
The recall affects the following lot numbers: 25128L1C0, 25280L1C0, and 26108L1C0. These multi-dose vials were distributed nationwide, and healthcare providers, distributors, and consumers are advised to stop using the products and return them to the place of purchase.
American Regent, Inc. received customer complaints regarding leaking and cracked vials, which led to the investigation and subsequent recall. The firm’s investigation revealed that these vials could pose serious health risks, including blockage and clotting in blood vessels, which can lead to life-threatening conditions such as pulmonary embolism and permanent organ damage.
According to the risk statement, the presence of particulate matter in the injection could cause local vein irritation, inflammatory reactions, and allergic reactions. Cracked vials can compromise the integrity of the container, leading to a loss of sterility and potential contamination. Despite these risks, American Regent has not yet received any reports of adverse events related to the recalled product.
Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) is used for the emergency treatment of allergic reactions, including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. The clear, colorless, sterile solution is packaged in a 30 mL multiple-dose vial containing 1 mg/mL.
Customers and healthcare professionals are advised to contact American Regent Inc. if they have concerns about the recalled product. Patients using the affected product are urged to stop using it and contact their doctor or healthcare provider.
American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this action to protect public health.