EPINEPHRINE Injection — Class II drug recall D-0483-2026
Ongoing recall by International Medication Systems Ltd., reported 2026-04-22, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0483-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Medication Systems Ltd., South El Monte, CA, United States |
| Recall initiated | 2026-04-01 |
| Classified | 2026-04-14 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 81,520 units |
| Reason classes | sterility |
| NDC | 76329-3318, 76329-3318-01 |
| Lot numbers | EA038A5 |
| Expiration dates | 2026-08 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0483-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.