American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the…

Possible metal contamination. Do not eat it.

What the notice says

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility. The firm’s investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass. Risk Statement: Intravenous administration of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) containing particulate matter may lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Additionally, cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients. To date, American Regent has not received any reports of adverse events related to this recall. Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) packaged in a multi dose vials, administered intravenously, intramuscularly, or subcutaneously and is to be used by or under the direction of a physician. Epinephrine Injection, USP is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercis.

What to do

1. 1Do not eat it until you confirm your lot is not affected.
2. 2Compare lot, UPC, and dates with the recall details.
3. 3Check back — the hazard class may be added soon.

Recall details

Firm

American Regent, Inc.

Status

Announced

Reported

Sep 3, 2026

Started

Sep 3, 2026

Notice number

american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30

Lots, UPC, dates

Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) packaged in a multi dose vials, administered intravenously, intramuscularly, or subcutaneously and is to be used by or under the direction of a physician. Epinephrine Injection, USP is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine Injection, USP is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine Injection, USP is a clear, colorless, sterile solution available in a 30 mL multiple-dose vial containing 1 mg/mL. The affected Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide, in the United States.