American Regent, Inc. recalls Epinephrine Injection
- Recalling company
- American Regent, Inc.
- Product
- Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
- Reason
- Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Aug 11, 2026
- Reported
- Sep 16, 2026
- Distribution
- Nationwide within the U.S.A
- Status
- Ongoing
- Quantity
- 31,935 30mL-vials
- Lot / codes
- Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
- Company location
- Shirley, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0865-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0865-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.