Par Health Issues Nationwide Recall of Argatroban Injection Due to Particulate Matter

Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. The recall is due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially stainless steel, detected in certain lots. Administration of the affected injection has a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels, and/or inflammation of vein walls, which may lead to clotting. To date, no adverse events related to this recall have been reported. The affected lots were distributed nationwide to wholesalers and hospitals between December 30, 2024, and May 5, 2026.