Recall Notification: Argatroban Injection 250 mg/2.5 mL (COM-2026-041)

PharmPix is committed to the health and wellness of our members. The clinical team wants to communicate the latest up-to-date drug recall.

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On October 14, 2026, the U.S. Food and Drug Administration published a voluntary nationwide recall issued by Par Health USA, LLC covering 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL), a direct thrombin inhibitor used for the prophylaxis or treatment of thrombosis in adults with heparin-induced thrombocytopenia and as an anticoagulant during percutaneous coronary intervention in adults with or at risk for HIT.

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Reason for Recall

Particulate matter was identified in the recalled lots, consisting of cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. Administration of product containing particulate matter has a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli, occlusion of other blood vessels leading to tissue death and possible organ damage, and inflammation of vein walls that may lead to clotting. To date, Par Health has not received any reports of adverse events related to this recall.

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Required Action

Check all inventory locations where this product may be held. Quarantine any affected lots and immediately stop use, dispensing, and further distribution. If you have distributed the product to other accounts or locations, notify them of this recall.  

Par Health is arranging return of all existing inventory through Inmar, Inc. For recall and return questions, contact Inmar at 1-855-648-7909, Monday through Friday, 9 a.m. to 5 p.m. ET, or rxrecalls@inmar.com. For medical or technical questions, contact Par Health at 1-800-828-9393.  

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Full announcement: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-argatroban-injection-due-presence-particulate-matter  

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Vial labels may read “Distributed by: Par Pharmaceutical” or “Endo USA” rather than Par Health. Verify by NDC and lot number, not by distributor name.

Remember you can report adverse events related to this or any other drug product at MedWatch: The FDA Safety Information and Adverse Event Reporting Program by any of the following ways:

• Complete and submit the MedWatch Online Voluntary Reporting Form online.

• Download FDA Form 3500 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

• Additional information can be found at: MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

If you have any questions or wish to have more information regarding this document, you can call us at 787-522-5252-ext.219. Our pharmacists will help you.

In addition, know that you can access our recent communications at our providers’ portal: https://www.pharmpix.com/providers/.

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