American Regent recalls 3 epinephrine injection lots over leaks, cracked vials

American Regent, Inc. is recalling three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multi-dose vials nationwide at the consumer level after customer complaints about leaking and cracked vials, the company said in a Sept. 3, 2026 notice.

The company said the defects created a lack of assurance of sterility. American Regent also said its investigation identified particulate matter described as Nylon, Cellulosic, Acrylic, Polyethylene and Glass.

The affected lot numbers are 25128L1C0, 25280L1C0 and 26108L1C0. American Regent said the lots were distributed nationwide in the United States.

The product is described in the notice as a clear, colorless, sterile solution in a 30 mL multiple-dose vial containing 1 mg/mL epinephrine. It is administered intravenously, intramuscularly or subcutaneously and used by or under the direction of a physician.

According to the recall notice, intravenous administration of product containing particulate matter may cause serious adverse health consequences, including blockage and clotting in blood vessels, pulmonary embolism, permanent organ damage or death. The notice also lists possible local vein irritation, inflammatory reaction, aggravation of preexisting infections and allergic reactions.

American Regent said it had not received reports of adverse events related to the recall at the time of the notice. The company said it is notifying distributors and customers by letter and arranging return or replacement of the recalled product.

Distributors, retailers and healthcare facilities with the product are instructed to stop use and return it to the place of purchase or discard it. Patients using the recalled product are told to stop using it and contact a doctor or healthcare provider.

The recall was conducted with the knowledge of the U.S. Food and Drug Administration, according to the notice.

The notice also says recall, return, replacement, credit, product quality complaint and medical information phone lines are available.

Sources

• PR Newswire: American Regent recall notice

Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.