FDA-Drug2026-09-16Class IPROCESSING DEFECT
American Regent epinephrine injection recalled for particulate matter and sterility concerns
What this means
American Regent's epinephrine injection (1 mg/mL, 30 mL vials) may contain particulate matter—including nylon, glass, and other materials—and some vials are broken or leaking. This affects the sterility and safety of the medication. Three specific lot numbers distributed nationwide are involved.
- Check your pharmacy or facility for vials matching lot numbers 25128L1C0, 25280L1C0, or 26108L1C0.
- Do not use affected vials; return them to your pharmacy or supplier immediately.
- Contact your healthcare provider or pharmacy if you have questions about your epinephrine supply.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S.A
Affected count
31,935 30mL-vials
Manufactured in
5 Ramsay Rd, Shirley, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2026More American Regent recalls
- FDA-PR2026-09-03American Regent epinephrine injection recalled for particulate matter and sterility concerns
- FDA-Drug2026-08-26American Regent Cyanocobalamin injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Tralement trace elements injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent aminocaproic acid injection recalled for particulate contamination
- FDA-Drug2026-08-26American Regent Selenious Acid Injection recalled for particulate contamination
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