EPINEPHRINE
Recalling Firm / Manufacturer: Fresenius Kabi USA, LLC
(Lake Zurich, IL, United States)
FDA Recall Number: D-0581-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
EPINEPHRINE
Generic Name
EPINEPHRINE
Active Substance(s)
Epinephrine
Administration Route
Intramuscular
National Drug Code (NDC)
63323-696
Total Quantity Recalled
898,050 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradations Specifications
Full Product Description
Packaging specifications and labeling details
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
June 17, 2026
Firm Initiation Date
May 14, 2026
FDA Classification Date
Jun 05, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
Distribution Information
Geographic scope of affected shipments
US Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Related Questo Medical Knowledge
Clinical cases and condition overviews related to this medication
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0581-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508602UTCC