Nearly two dozen lots of a common blood thinner medication are being recalled after foreign matter was found floating in the intravenous solution.
Par Health USA LLC has issued a voluntary nationwide recall for 22 lots of Argatroban Injection 250 mg/2.5 mL, citing cellulose and potentially stainless steel contamination.
The U.S. Food and Drug Administration warns the drugs have “a reasonable probability of causing life-threatening adverse health consequences.”
Such consequences include blocked blood vessels, organ damage and blood clots among other complications.
Argatroban Injection is a common drug used to treat or prevent blood clots in adult patients suffering from heparin-induced thrombocytopenia.
The recall was initiated at the hospital and user level after tests revealed particles identified as cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel inside certain batches.
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Despite the severe risks, Par Health stated it has not received any reports of adverse medical events related to the recall to date.
The 22 affected lots were distributed to hospitals and wholesalers nationwide between Dec. 30, 2024, and May 5, 2026.
Par Health is instructing medical facilities and wholesale distributors to immediately halt the use and distribution of the affected inventory.
If distributors have already sent the medication to secondary locations, they are urged to notify those accounts immediately.
Hospitals and pharmacies are being directed to return the recalled medications through the logistics company Inmar Inc.
Facilities with questions regarding the return process can contact Inmar at 1-855-648-7909.
For more information or to report an adverse event, patients and providers can call Par Health at 1-800-828-9393.
Adverse reactions can also be reported directly to the FDA’s MedWatch Adverse Event Reporting program online or by calling 1-800-332-1088.