Par Health Recalls Argatroban Injection Over Particulate Matter

Par Health USA is recalling 22 lots of its Argatroban Injection after particulate matter — identified as cellulose, polystyrene, polyethylene terephthalate and possibly stainless steel — was found in vials of the injectable anticoagulant. The recall, announced 13 October, is the Endo-owned manufacturer's third U.S. product recall in roughly a month, following a dexmedetomidine recall in September and a Brevital sodium recall in early October.

What is affected

Argatroban is a direct thrombin inhibitor given intravenously, used mainly as an anticoagulant in patients with, or at risk for, heparin-induced thrombocytopenia (HIT) — a setting where heparin itself cannot safely be used. It is listed among FDA's essential medicines and has had intermittent supply constraints in recent years, which raises the operational stakes of pulling product from hospital shelves rather than simply swapping in an alternate supplier's lot.

Par Health's recall covers 22 lots of its 250 mg/2.5 mL (100 mg/mL) single-dose vials, split across two National Drug Codes: NDC 42023-182-01, roughly 20 lots, and NDC 42023-182-89, two further lots. The affected product was distributed to wholesalers, distributors and hospitals between December 30, 2024, and May 5, 2026, with expiration dates running from October 2026 through September 2027 — meaning some recalled vials would otherwise have remained in active use for close to another year. The company's notice instructs wholesalers and hospital pharmacies holding the product to stop using it and quarantine remaining stock immediately.

Why it was pulled

The stated reason is particulate contamination: certain lots were found to contain cellulose, polystyrene, polyethylene terephthalate (a common packaging plastic) and stopper material, with stainless steel also possible. Par Health's own notice characterizes the risk in stark terms — administering a contaminated dose carries a reasonable probability of life-threatening adverse health consequences, including pulmonary emboli, occlusion of other blood vessels, and thrombophlebitis, the inflammation of a vein wall that can follow an injected irritant or foreign material. That is the company's characterization of the hazard, not a classification FDA has yet published for this specific recall; Regulatory News has not seen an FDA enforcement-report entry assigning this recall a formal risk class and is not asserting one here.

A third recall in a month

This is not an isolated event for the manufacturer. Par Health, part of Endo, recalled a dexmedetomidine product on September 18 and a lot of Brevital sodium (methohexital), used in anesthesia and ECT procedures, on October 8 — both covered separately on this site. Three product recalls from the same manufacturer inside roughly a month is the kind of pattern RA/QA teams tracking supplier quality should flag on its own terms, independent of whether any single recall proves to carry FDA's highest risk classification: it raises the question of whether the three incidents share a common root cause in manufacturing or quality-control processes, something Par Health's public notices have not yet addressed.

Frequently asked questions

What is being recalled?

Par Health USA, LLC is voluntarily recalling 22 lots of Argatroban Injection, 250 mg/2.5 mL (100 mg/mL single-dose vials), to the hospital and user level. The recalled lots fall under two NDCs, 42023-182-01 and 42023-182-89, with expiration dates ranging from October 2026 to September 2027. The company's announcement, posted through FDA's recalls page, is dated October 13, 2026.

Why is it being recalled?

For the presence of particulate matter identified in certain lots as cellulose, polystyrene, polyethylene terephthalate (PET), stopper material and possibly stainless steel. The company says administering contaminated product carries a reasonable probability of life-threatening harm, including pulmonary emboli, occlusion of other blood vessels, and thrombophlebitis (inflammation of a vein wall).

Has anyone been harmed?

Par Health says it has not received any reports of adverse events related to this recall as of the announcement.

Has FDA published a formal risk classification for this recall?

Not as of this writing. FDA's enforcement reports, which assign a recall a Class I, II or III designation, typically lag a company's initial recall announcement by one to several weeks. Regulatory News has not seen a classification for this recall and is not asserting one; the hazard language above is the company's own, as published in its recall notice.