Par Health USA is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) after particulate matter was detected in certain lots, according to the company announcement posted by the FDA. The particles were identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The company announced the nationwide recall on October 13, 2026, and it extends to the hospital and user level.
Argatroban is an intravenous blood thinner given in hospitals. It is used to prevent or treat clots in adults with heparin-induced thrombocytopenia (HIT), a reaction to the common blood thinner heparin. It is also used as an anticoagulant in adults with or at risk for HIT who are undergoing percutaneous coronary intervention, a procedure to open narrowed heart arteries.
