Recall Issued for Tirofiban Hydrochloride Injections Due to Stability Failures
The US Food and Drug Administration (FDA) has announced a Class II recall involving 2 formulations of Tirofiban Hydrochloride Injection—5 mg/100 mL and 12.5 mg/250 mL—manufactured in India for Eugia U.S. LLC, based in East Windsor, New Jersey. The recall affects Lot #3TF24002A (5 mg/100 mL, Exp. 11/30/2026) and Lot #3TF24001 (12.5 mg/250 mL, Exp. 3/31/2026) after out-of-specification (OOS) results were obtained during 3-month stability testing, indicating potential degradation of related substances. A total of 18 867 bags of the 5 mg formulation were distributed across the United States; quantities for the 12.5 mg product were not specified.
The voluntary recall was initiated on April 21, 2025, and officially classified as Class II by the FDA on April 25, 2025, signifying that use of the affected products may result in temporary or medically reversible adverse health effects. However, the likelihood of serious harm is remote. The recalling firm, Eugia U.S. LLC, notified customers via letter, and while no public press release has been issued, health care providers and pharmacists nationwide are urged to identify and remove impacted lots from inventory.
Tirofiban is a glycoprotein IIb/IIIa inhibitor used to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS), such as unstable angina or non-ST elevation myocardial infarction (NSTEMI). As this drug is typically administered in high-acuity settings like cardiac catheterization labs, maintaining product potency and integrity is essential.
