Epinephrine Recall: Sterile Vials Leaked, Cracked

American Regent has announced a voluntary nationwide recall for three specific lots of Epinephrine Injection, USP 30 mg/30 mL multi-dose vials. This recall was prompted by numerous customer reports detailing vials that were either leaked or cracked, compromising their sterility.

During its investigation, the company discovered particulate matter within the affected vials. The identified materials included nylon, cellulosic, acrylic, polyethylene, and glass. Intravenous injection of such particles can lead to severe complications, including vascular blockages, reduced blood flow to vital organs, fatal pulmonary embolism, irreversible organ damage, and even death.

Furthermore, cracked vials present an independent hazard by allowing potential contamination, absent in intact containers. The recall encompasses lot numbers 25128L1C0, 25280L1C0, and 26108L1C0, distributed between September 2025 and July 2026. American Regent has stated no adverse events have been reported in connection with this recall.

Epinephrine injections are critical for the emergency treatment of severe allergic reactions, such as anaphylaxis, and for increasing blood pressure in cases of septic shock. The company is working directly with distributors and customers to facilitate the return or replacement of all recalled units. Healthcare providers are instructed to stop using and return or discard affected products. Patients should discontinue use and consult their doctor immediately.