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

FDA recall notice · announced April 22, 2026 · International Medication Systems

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot Number: EA038A5, Expiration Date: 08/2026.
Quantity: 81,520 units
Status: Ongoing
Products in this recall event:
- 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 (D-0483-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.