Par Health issues nationwide recall of Argatroban injection due to particulate matter contamination

On October 14, 2026, the FDA announced that Par Health USA initiated a voluntary nationwide recall of 22 lots of Argatroban Injection due to the presence of particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. Argatroban is a direct thrombin inhibitor used for patients with heparin-induced thrombocytopenia. Administration of the contaminated product could cause life-threatening adverse events including pulmonary emboli, blood vessel occlusions, and vein inflammation leading to clotting. The affected lots were distributed nationwide between December 2024 and May 2026.

Claims

• ▪To date, Par Health has not received any reports of adverse events related to this recall.
• ▪The affected lots were distributed nationwide to wholesalers and hospitals between December 30, 2024, and May 5, 2026.
• ▪Adverse reactions can be reported to the FDA MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
• ▪Par Health USA recalled 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) due to the presence of particulate matter including cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.
• ▪The recall was conducted with the knowledge of the U.S. Food and Drug Administration.
• ▪The FDA drug recall system catches contamination issues before they reach patients
• ▪Administration of Argatroban Injection containing particulate matter could cause life-threatening adverse health consequences including pulmonary emboli, blood vessel occlusions, and vein inflammation leading to clotting.
• ▪The FDA also announced multiple food recalls in October 2026 including Listeria-contaminated smoked salmon and Salmonella-contaminated broccoli seeds.
• ▪The recall is being conducted to the hospital and user level, with Par Health arranging for return of all existing inventory through Inmar, Inc.
• ▪Pharmaceutical manufacturing quality standards are sufficient to prevent particulate contamination
• ▪Argatroban is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia and as an anticoagulant in percutaneous coronary intervention.