⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

American Regent, Inc.: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneou

DrugsSource: FDA (drug) · Date: 2026-09-16

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
American Regent, Inc.
Product
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
Reason / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
Nationwide within the U.S.A
Recall initiated
2026-08-11
Code info
Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
Product quantity
31,935 30mL-vials
Voluntary mandated
Voluntary: Firm initiated
City
Shirley
State
NY
Country
United States
Event id
99670
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