Par Health recalls 22 argatroban injection lots

Revision 1 · Drug safety · United States · Record prepared

Prepared through Iliyn’s AI-assisted editorial workflow. Source statements are not independent audits of underlying events.

An FDA-posted company notice identifies 22 lots of argatroban injection recalled nationwide because of particulate matter.

What the record says

Par Health’s October 13 announcement, posted by FDA October 14, covers Argatroban Injection 250 mg/2.5 mL (100 mg/mL), distributed under Par Pharmaceutical or Endo USA names. The lots were sent to wholesalers and hospitals nationwide between December 30, 2024, and May 5, 2026. The notice warns of serious risks from particulate matter and says no related adverse-event reports had been received at the time of the announcement.

Source details and supporting locations.

Practical next step

Hospital pharmacies and wholesale distributors should compare inventory with the official 22-lot table and follow the notice’s stop-use, stop-distribution and return instructions. Patients with treatment questions should contact their care team.

Limits and what is not established

This recall concerns listed lots and the specified concentration, not all argatroban products. FDA hosts the company announcement; this record does not assign a recall classification or establish harm in an individual patient.

Sources checked October 17, 2026. Later notices may change instructions or arrangements.

Original sources

Par Health company announcement posted by FDA: original information

Corrections and history

Read correction history

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