EPINEPHRINE
Recalling Firm / Manufacturer: American Regent, Inc.
(Shirley, NY, United States)
FDA Recall Number: D-0865-2026
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)
0517-3030
Total Quantity Recalled
31,935 30mL-vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Full Product Description
Packaging specifications and labeling details
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
September 16, 2026
Firm Initiation Date
August 11, 2026
FDA Classification Date
Sep 22, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
Distribution Information
Geographic scope of affected shipments
Nationwide within the U.S.A
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
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-0865-2026
Questo Retrieval Date: September 29, 2026 12:00 1790683214UTCC