August 2026 FDA Recall Epinephrine by American Regent, Inc.
D-0865-2026 - 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.

This Class I drug recall was voluntarily initiated by American Regent, Inc. on August 11, 2026 for the product Epinephrine. The FDA reported the reason for recall as 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 product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0865-2026

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.
Initiated
08-11-2026
Reported
09-16-2026
Quantity
31,935 30mL-vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99670
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is 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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Regent, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the U.S.A
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0517-3030-01 Epinephrine