Clinical Report: Argatroban Injection Recalled Over Particulate Risk

Overview

Par Health USA voluntarily recalled 22 lots of argatroban injection nationwide after detecting particulate contamination. The company warned that administration could cause serious vascular complications, including pulmonary emboli, vascular occlusion with possible tissue or organ damage, and venous inflammation that may lead to clot formation; no associated adverse events had been reported as of October 13, 2026.

Background

Argatroban is an intravenous 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 who undergo percutaneous coronary intervention. The recall concerns specified lots distributed under the Par Health and Endo USA names, rather than all argatroban injection products. The FDA posted the company’s recall announcement on October 14, 2026.

Data Highlights

Key Findings

• Par Health USA initiated a voluntary nationwide recall of 22 lots distributed under the Par Health and Endo USA names.
• The company identified particulate matter that included cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.
• The company warned of a reasonable probability of serious adverse health consequences, including pulmonary emboli, other vascular occlusions that could cause tissue death or organ damage, and venous-wall inflammation that may lead to clot formation.
• The affected lots were distributed to wholesalers and hospitals between December 30, 2024, and May 5, 2026; the recall is limited to the specified lots.
• Wholesale distributors and hospital pharmacies possessing affected products were instructed to discontinue use and distribution immediately. Facilities that redistributed affected lots were asked to notify downstream accounts and locations.
• Par Health reported no adverse events associated with the recalled products as of October 13, 2026, and said it was arranging returns through Inmar, Inc.

Clinical Implications

Healthcare facilities should identify the affected NDCs and lots, discontinue their use and distribution, and notify downstream recipients if products were redistributed. Product-return questions may be directed to Inmar at 1-855-648-7909 or rxrecalls@inmar.com; medical or technical inquiries and reports of complaints or adverse events may be directed to Par Health at 1-800-828-9393. Suspected adverse events or product-quality problems may also be reported through FDA MedWatch.

Conclusion

The recall addresses a defined set of argatroban injection lots with particulate contamination and a company-stated risk of serious vascular complications. The FDA posted the recall notice, and the company reported no associated adverse events as of October 13, 2026.

Related Resources & Content

1. Par Health USA, US Food and Drug Administration, 2026 -- Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter
2. US Food and Drug Administration, 2026 -- Argatroban Injection: Prescribing Information
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6. kff health news — FDA 'Recalls' Often Leave Devices in Use
7. Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter
8. Argatroban Injection: Prescribing Information
9. Inspection of Injectable Products for Visible Particulates | FDA
10. © 2025 USPC - 788 PARTICULATE MATTER IN INJECTIONS
11. American Society of Hematology 2018 guidelines for management of venous thromboembolism: heparin-induced thrombocytopenia - PMC
12. ASH VTE Guidelines: Heparin-Induced Thrombocytopenia (HIT) - Hematology.org
13. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines | JACC
14. Comparative effectiveness of parenteral anticoagulants (fondaparinux, argatroban, bivalirudin) in heparin-induced thrombocytopenia: A systematic review - PMC
15. Outcomes of patients with suspected heparin-induced thrombocytopenia in a contemporary multicenter cohort - ScienceDirect