Par Health USA is recalling 22 lots of Argatroban Injection, 250 mg per 2.5 mL, after particulate matter was found in the vials, and hospitals and wholesalers have been told to stop using and distributing the product. The recall is nationwide and reaches the hospital and user level. The company announced it on Oct. 13, 2026, and the Food and Drug Administration posted the notice the next day.
Argatroban is a blood thinner used in a narrow group of patients, so the recall lands mostly on hospital pharmacies and cardiac and intensive care units rather than on retail shelves. Par Health says it has not received any reports of adverse events related to the recall.
The particles and the 22 lots
According to the company notice posted by the FDA, the particulate matter was identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. Two of those are plastics, one is paper-derived fiber, one comes from the rubber closure of the vial itself, and the last would point to metal. The notice does not say how the particles got in or whether they came from one step in manufacturing.
The 22 lots fall under two product codes. Twenty carry National Drug Code 42023-182-01 and two carry 42023-182-89. Expiration dates run from October 2026, for lots 83449 and 84193, to September 2027 for lot 93890, and the lots were distributed to wholesalers and hospitals nationwide between Dec. 30, 2024, and May 5, 2026. A hospital pharmacist checking shelves would compare lot number and code against the table in the notice rather than rely on the expiry date, since lots with different expirations are all included.
The product carries the names Par Pharmaceutical or Endo USA on its label, and the notice explains that Par Pharmaceutical, Inc. and Endo USA, Inc. are predecessor companies to Par Health USA, LLC, which is based in Rochester, Michigan. Representative images of the vial labels are included in the FDA posting so that staff can match what is on the shelf. Anyone holding product from the listed lots is told to discontinue use immediately, and the notice draws no distinction between vials that look clear and vials that do not within a recalled lot.
Par Health’s account of the particulate risk
Par Health stated that administering the affected product “has a reasonable probability of causing life-threatening adverse health consequences.” The notice lists three possible outcomes: pulmonary emboli, which are blockages in the blood vessels of the lungs; blockages in other blood vessels, which can lead to tissue death and possible organ damage; and inflammation of the walls of veins, which may lead to clotting. Those risks follow from injecting solid particles directly into the bloodstream, and they are the basis for the company’s statement about life-threatening consequences.
That the company has received no adverse event reports to date means little about whether exposure occurred. Vials with particles are not always noticed before they are used, and a clot in a patient who is already being treated for a clotting disorder can be hard to trace to any single cause.
Why argatroban is hard to substitute
Argatroban is a direct thrombin inhibitor. The product is indicated for preventing or treating thrombosis in adults with heparin-induced thrombocytopenia, a reaction in which heparin, the usual anticoagulant, causes platelet counts to fall and clots to form, and as an anticoagulant for adults with or at risk for that condition who are undergoing percutaneous coronary intervention. The clinical rationale for using argatroban in that setting is laid out in a review titled “Argatroban in heparin-induced thrombocytopenia: rationale for use and place in therapy.” Because heparin is the drug that triggers the reaction, pharmacies treating these patients cannot simply substitute it when a lot is pulled, and need another approved option on hand.
Par Health describes its response in three steps. Written notification is going to wholesale and hospital accounts that received the lots, entities that further distributed the product are to notify their own customers, and returns of all existing inventory are being arranged through Inmar. Recall questions go to Inmar at 1-855-648-7909 on weekdays, and clinicians with product complaints or medical questions can call Par Health at 1-800-828-9393.
Reporting problems and tracking the recall
Adverse reactions or quality problems can be reported to the FDA through MedWatch, either online or by mail or fax. The agency also keeps recall notices in its recalls, market withdrawals and safety alerts listing and publishes them through an RSS feed of recalls.
The recall is being conducted with the knowledge of the FDA, which posted the company’s announcement but has not, in the page text, assigned a classification. That classification, when it comes, will show how the agency rates the risk of the particles. For now, the instruction to hospitals is the one in the notice: immediately discontinue use and stop distribution of the listed lots.
This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.
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