The recall affects lots 25128L1C0, 25280L1C0, and 26108L1C0, which were distributed nationwide between September 2025 and July 2026. Testing identified foreign debris within the vials, specifically nylon, cellulosic, acrylic, polyethylene, and glass particles. Because these vials are intended for emergency use—often in life-threatening scenarios like anaphylaxis or septic shock—the lack of sterility assurance creates a critical safety gap.

Intravenous administration of contaminated solution can trigger severe inflammation, allergic reactions, or vessel blockages. Healthcare providers and pharmacies are instructed to immediately quarantine the affected stock and arrange for its return. Patients currently in possession of the medication should halt use and consult their physician to secure an alternative supply. American Regent is coordinating the recall with the FDA and providing direct guidance to distributors on replacement procedures.