Epinephrine Injection…

Date

Sept. 16, 2026

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Ongoing

Filed by

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

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.

Distribution pattern

Nationwide within the U.S.A

Quantity

31,935 30mL-vials

Codes and lots

Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027

Recall started

Aug. 11, 2026

Recall number

D-0865-2026

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0865-2026. The agency record governs; check it and the company before acting.