Recall - American Regent, Inc. (Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial) produced by American Regent, Inc. - Presence of particulate matter and lack[...]

Summary

Company Announcement

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 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.

Specific NDC numbers, lot numbers, expiration dates and distribution dates can be found in the table below.

American Regent, Inc. is notifying its distributors and customers by letter and is arranging for return/replacement etc. of all recalled products.

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.

Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this action to protect public health.