Epinephrine Recall: International Medication Systems 1 mg/10 mL
Announced 2026-04-22 · FDA
International Medication Systems Ltd. is recalling Epinephrine Injection, USP, 1 mg/10 mL (Rx only) due to lack of assurance of sterility. About 81,520 units distributed nationwide in the U.S. are affected. The lot affected is EA038A5 with an expiration date of 08/2026.
| Brand | International Medication Systems Ltd. |
|---|---|
| Product | EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1 |
| Reason | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 81520 |
| Distribution | U.S. Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot Number: EA038A5, Expiration Date: 08/2026. |
WHAT YOU SHOULD DO
- Do not use this product.
- Contact your healthcare provider or pharmacist for guidance.
- If you have the recalled lot EA038A5, stop using it and return it to the place of purchase for disposal or replacement.
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.