Par Health USA, LLC announced a Class I recall of Argatroban Injection, USP, 250 mg/2.5mL, on October 13, 2026. The recall affects products distributed nationwide and is ongoing due to the presence of particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution. Details of the recall can be found in the FDA's weekly enforcement report here.

Press Release: Food and Drug Administration

Published October 28, 2026. Reproduced in full from the Food and Drug Administration.

Par Health USA, LLC drug recall

  • Recalling company: Par Health USA, LLC
  • Classification: Class I (the most serious type)
  • Recall numbers: D-0082-2027, D-0083-2027
  • Status: Ongoing
  • Distribution: Nationwide within the United States
  • Recall started: October 13, 2026

What was recalled

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.

Why

Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

This drug recall appears in the FDA's weekly enforcement report. Details: FDA recall event 100072.