American Regent is conducting a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials, after reports of leaking and cracked vials and the discovery of particulate contamination.
Announced September 3, 2026, the recall stems from customer complaints about compromised vials — which means a lack of assurance of sterility — and the company’s investigation found particles identified as nylon, cellulosic, acrylic, polyethylene and glass. This is a hospital/pharmacy bulk product, not a consumer auto-injector.
The risk
The dangers are serious. Injecting epinephrine that contains particulate matter could cause blockages and blood clots — cutting off blood flow to vital organs, triggering a life-threatening pulmonary embolism (a clot in the lungs), and potentially causing permanent organ damage or death. Cracked vials can also allow contamination, adding infection risk.
What to do
The affected lots were distributed between September 4, 2025 and July 31, 2026. Health-care facilities, retailers and consumers should stop using the recalled product and discard or return it; American Regent can be reached at 1-800-645-1706. Epinephrine is a critical emergency medicine (used for cardiac emergencies and severe allergic reactions), so facilities should quarantine affected stock and ensure unaffected supply is on hand. This is a recall notice; follow official FDA/manufacturer guidance.