EPINEPHRINE Injection recall (International Medication Systems Ltd.)
DrugClass IIOngoing
Summary: International Medication Systems Ltd. is recalling 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.
What is being recalled
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
Why
Lack of Assurance of Sterility
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot Number: EA038A5, Expiration Date: 08/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0483-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 1, 2026 |
| Reported | April 22, 2026 |
| Company | International Medication Systems Ltd. |
| Company location | South El Monte, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 81,520 units |
More recalls from International Medication Systems Ltd. · all drug recalls · recalls from April 2026