Par Health USA has voluntarily recalled 22 lots of argatroban injection, 250 mg/2.5 mL (100 mg/mL), nationwide after detecting particulate contamination that poses a risk of serious vascular complications.

The recall affects products distributed under the Par Health and Endo USA names and extends to the hospital and user level. According to the company announcement published by the US Food and Drug Administration (FDA) on October 14, the particles included cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.

Par Health warned that administration of affected injections has a reasonable probability of causing serious adverse health consequences. These include pulmonary emboli, occlusion of other blood vessels potentially resulting in tissue death or organ damage, and inflammation of venous walls that may lead to clot formation.

The company reported no adverse events associated with the recalled products as of its October 13 announcement.

Argatroban is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adults with heparin-induced thrombocytopenia (HIT). It is also indicated for anticoagulation in adults with or at risk for HIT undergoing percutaneous coronary intervention.

The affected lots were distributed to wholesalers and hospitals across the United States between December 30, 2024, and May 5, 2026.

The recall involves 2 National Drug Codes (NDCs): 42023-182-01, covering 20 lots, and 42023-182-89, covering 2 lots. The affected products carry expiration dates ranging from October 2026 through September 2027. The recall is limited to the specified lots rather than all argatroban injection products.

Par Health is notifying wholesale distributors and hospital accounts and arranging for the return of affected inventory through Inmar, Inc.

Wholesale distributors and hospital pharmacies possessing recalled products should immediately discontinue their use and distribution. Facilities that have redistributed affected lots should notify downstream accounts and locations that may have received them.

The recall is being conducted with the FDA's knowledge. Questions regarding product returns can be directed to Inmar at 1-855-648-7909 or rxrecalls@inmar.com. Medical or technical inquiries and reports of product complaints or adverse events can be directed to Par Health at 1-800-828-9393.

Health care professionals may also report suspected adverse events or product quality problems through the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Sources

Par Health USA. Par Health issues voluntary nationwide recall of argatroban injection due to the presence of particulate matter. US Food and Drug Administration. Published October 14, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-argatroban-injection-due-presence-particulate-matter

 US Food and Drug Administration. Argatroban injection: prescribing information. Revised 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/201811s012lbl.pdf