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 |
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.
How to identify the recalled item
| Lot / date codes | Lot Number: EA038A5, Expiration Date: 08/2026. |
|---|---|
| Lot / date codes | Lot Number: EA038A5, Expiration Date: 08/2026. |
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
- Epinephrine Recall: American Regent 30 mg/30 mL MDV · 2026-09-16
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.