Epinephrine Injection
FDA Recall NDC 76329-3318
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Epinephrine (NDC 76329-3318). A significant event, classified as Class II, was initiated on Apr 01, 2026 by International Medication Systems, Limited. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Apr 01, 2026
Apr 22, 2026
81,520 units
Recall Profile & Regulatory Data
Event ID
98690
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
International Medication Systems Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
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
Batch or Lot Expiration Information
Lot# Lot Number: EA038A5, Expiration Date: 08/2026.
Affected Packages Involved in this Recall
76329-3318-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
