American Regent, Inc. — 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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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.

Provider

FDA — drug enforcement reference

Source observed

9/16/2026, 12:00:00 AM UTC

Source updated

9/16/2026, 12:00:00 AM UTC

Location

Shirley, NY, US

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.

notice

Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.

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

distribution

Nationwide within the U.S.A

manufacturer

American Regent, Inc.

recall number

D-0865-2026

source status

Ongoing

classification

Class I

freshness minutes

180

Source use policy · openFDA reference data; not a real-time public alert service

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