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Home › FDA recalls › EPINEPHRINE Injection
CLASS II · ModerateFDA

International Medication Systems Ltd. recalls EPINEPHRINE Injection

📅 Apr 1, 2026 · 📍 Nationwide
Recalling company
International Medication Systems Ltd.
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
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 1, 2026
Reported
Apr 22, 2026
Distribution
U.S. Nationwide
Status
Ongoing
Quantity
81,520 units
Lot / codes
Lot Number: EA038A5, Expiration Date: 08/2026.
Company location
South El Monte, CA
Recall type
Voluntary: Firm initiated
Recall number
D-0483-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0483-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.