EPINEPHRINE Injection recalled over sterility concerns

Recall date

April 1, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

International Medication Systems Ltd. recalls EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA…

Recall number

D-0483-2026

FDA classification

Class II

Brand / firm

International Medication Systems Ltd.

Sold / distributed

U.S. Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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