Tirofiban Hydrochloride Injection Recalled Due to Stability Failures
The US Food and Drug Administration (FDA) has issued a Class II recall for 2 formulations of Tirofiban Hydrochloride Injection—5 mg/100 mL and 12.5 mg/250 mL—due to out-of-specification (OOS) test results observed during long-term stability testing. Specifically, related substances exceeded acceptable limits after 3 months under long-term storage conditions. The affected lots include Lot #3TF24002A (5 mg/100 mL, exp. 11/30/2026) and Lot #3TF24001 (12.5 mg/250 mL, exp. 3/31/2026). The recall was initiated by Eugia US LLC on April 21, 2025, and remains ongoing with nationwide distribution in the United States.
The products were manufactured in India for Eugia US LLC, headquartered in East Windsor, New Jersey, which voluntarily initiated the recall. The FDA officially classified the recall as Class II on April 25, 2025, meaning that use of the product may cause temporary or medically reversible health consequences. Still, the risk of serious harm is remote. While no public press release has been issued, the company has notified consignees by letter. Pharmacists should immediately review inventory for affected lot numbers and coordinate product removal to prevent potential therapeutic failures.
Tirofiban is an antiplatelet agent indicated for the treatment of acute coronary syndrome (ACS), including patients with unstable angina or non-ST elevation myocardial infarction (NSTEMI), often used during percutaneous coronary interventions. Compromised product stability could impact drug potency and clinical efficacy in critical care scenarios.
