Warning
International Medication Systems Ltd. Recalls EPINEPHRINE Injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0483-2026Drug / Pharmaceutical
International Medication Systems Ltd. Recalls EPINEPHRINE Injection
International Medication Systems Ltd. · Class II — Moderate Risk
Product Description
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from International Medication Systems Ltd., initiated on April 1, 2026. Lack of Assurance of Sterility. This recall covers 81,520 units, distributed in U.S. Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.