Epinephrine Recall: American Regent 30 mg/30 mL MDV
The FDA is recalling American Regent, Inc. Epinephrine Injection, USP, 30 mg/30 mL, 30 mL-Multiple-Dose Vial, Rx Only, distributed nationwide. The recall is due to the presence of particulate matter and lack of assurance of sterility; particulate matter includes nylon, cellulosic, acrylic, polyethylene and glass, and some vials are broken or leaking. A total of 31,935 vials are affected across three lots: 25128L1C0 (Exp. August 31, 2026); 25280L1C0 (Exp. October 31, 2026); and 26108L1C0 (Exp. July 31, 2027).
| Brand | 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. |
| Severity | critical |
| Units affected | 31935 |
| Distribution | Nationwide within the U.S.A |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use recalled vials.
- Check if you have lot numbers 25128L1C0, 25280L1C0, or 26108L1C0 and discontinue use if matched.
- Contact your healthcare provider or supplier for replacement or disposal instructions.
How to identify the recalled item
| Lot / date codes | Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027 |
|---|---|
| Lot / date codes | Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other epinephrine recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.