FDA Drug recall D-0483-2026
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar… by International Medication Systems, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0483-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-01 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | International Medication Systems |
| Distribution | US |
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
Identifiers
| ndc | 76329-3318-1 |
|---|---|
| code_info | Lot Number: EA038A5, Expiration Date: 08/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0483-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.