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FDA recall, , High risk

American Regent Epinephrine Injection

Presence of Particulate Matter and Lack of Assurance of Sterility.

Summary by Recall Canary from the FDA notice

What happened

American Regent, Inc., of Shirley, New York, is conducting a nationwide voluntary recall of Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use. The recall was announced on September 3, 2026, and began on August 11, 2026.

The reason for the recall is the presence of particulate matter and lack of assurance of sterility, following customer complaints of broken and leaking vials. The firm's investigation reported the presence of glass particulates, and the particulate matter was identified as nylon, cellulosic, acrylic, polyethylene, and glass.

The recalled product was distributed nationwide within the U.S.A. The recall was added to the FDA's Enforcement Report on September 8, 2026, and classified by the FDA on September 22, 2026. The recall involves three lots of the product.

More sterility problem recalls

What to do

If a code on your package is listed below:

  1. Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product.
  2. Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information.
  3. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.
  4. Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.

Is yours affected?

Match your product and all the details in one listed combination.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. Epinephrine Injection, USP

    NDC
    • 0517-3030-01
    1. Lot code
      • 25128L1C0
      Best-by or expiration date
      August 2026
      Distribution
      September 04, 2025
    2. Lot code
      • 25280L1C0
      Best-by or expiration date
      October 2026
      Distribution
      December 16, 2025
    3. Lot code
      • 26108L1C0
      Best-by or expiration date
      July 2027
      Distribution
      June 15, 2026
  2. Distribution
    Beginning

Recall details

Company began the recall
Sold in

Nationwide within the U.S.A

Company
American Regent, Inc.Shirley, New York
Hazard
Sterility problem
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
99670
Recall number
D-0865-2026
Quantity recalled
31,935 30mL-vials

All recalls from American Regent, Inc.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Announced by the company · Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. In FDA's weekly enforcement report

  5. Classified by FDA

  6. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)