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High risk Drugs & MedicationsClass II

Epinephrine Injection Recall by Amphastar

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar

Updated April 1, 2026

International Medication Systems is recalling an epinephrine injection due to lack of assurance of sterility. Sterile injectable medications that are not properly sterilized can cause serious infections.

Is the International Medication Systems Ltd. recalled? Yes. This product was recalled by FDA on April 1, 2026. Details below.

What is recalled

Epinephrine Injection, USP, 1 mg/10 mL (0.1 mg/mL), prescription-only, manufactured by International Medication Systems Limited, South El Monte, California. NDC: 76329-3318-1. An Amphastar Pharmaceutical Company product.

Am I affected

You're affected if you have received or have in stock this epinephrine injection product with NDC 76329-3318-1 from International Medication Systems Limited.

What to do right now

If you have received this epinephrine injection, do not use it. Contact International Medication Systems Limited or your healthcare provider or pharmacy for guidance on obtaining a replacement dose.

The hazard

Lack of Assurance of Sterility

Brands affected

International Medication Systems Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0483-2026
Classification
Class II
Recalled
April 1, 2026
Read the official notice

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