D-0865-2026 Class I Ongoing
FDA drug recall D-0865-2026 was initiated by American Regent, Inc. on August 11, 2026 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 31,935 30mL-vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2026
- Initiation Date
- August 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,935 30mL-vials
Product Description
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 for Recall
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
Code Information
Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027