Daiichi Sankyo subsidiary American Regent is recalling three lots of generic epinephrine injection vials distributed across the United States amid concerns over particulate contamination and packaging failures.
The recall follows customer complaints of leaking and cracked vials, which have compromised American Regent’s ability to guarantee the sterility of the affected products.
An investigation into the complaints also revealed the presence of particulate matter within the vials, identified specifically as nylon, cellulosic, acrylic, polyethylene, and glass.
Injecting a drug containing foreign particulate matter can cause blockage and clotting of blood vessels, potentially resulting in organ damage or death, according to American Regent’s recall alert.
Particulate contamination can also trigger local vein irritation, inflammatory and allergic reactions, and may worsen preexisting infections in affected patients.
The recalled epinephrine product is used for emergency treatment of allergic reactions and anaphylaxis, and is administered intravenously, into the muscle, or under the skin by a physician.
Three specific lot numbers are covered by the action: 25128L1C0, 25280L1C0, and 26108L1C0, all distributed under NDC number 0517-3030-01, with distribution dates spanning September 2025 through July 2026.
Lot 25128L1C0 was distributed between September 4 and December 18, 2025, while lot 25280L1C0 shipped between December 16, 2025, and April 17, 2026.
As of September 3, American Regent confirmed it had not received any adverse event reports linked to the recalled batches.
The epinephrine vial line is relatively new to the market, having launched in October 2024 as an FDA-approved generic option for emergency resuscitation and shock management in hospital settings.
American Regent is notifying distributors and customers by mail, and consumers, retailers, and healthcare facilities are advised to stop using the product and discard or return it immediately.
Headquartered in Shirley, New York, American Regent operates as the US injectable drug subsidiary of Tokyo-based Daiichi Sankyo Group, Japan’s second-largest pharmaceutical company.
Particulate contamination remains a persistent industry-wide challenge, with FDA enforcement data showing that foreign particulate matter accounted for roughly 31% of all sterile injectable drug recalls between August 2017 and February 2024.