Par Health USA, LLC is voluntarily recalling 22 lots of Argatroban Injection nationwide after particulate matter was found in certain lots. The company announced the recall on October 13, 2026, and the FDA published it the next day. It is the company's third recall in about a month.
What's Being Recalled?
The product is Argatroban Injection 250 mg/2.5 mL (100 mg/mL), labeled "Distributed by: Par Pharmaceutical or Endo USA." It was shipped to wholesalers and hospitals between December 30, 2024 and May 5, 2026. NDC 42023-182-01 covers 20 lots: 83449, 82682, 86714, 87302, 87560, 87753, 88401, 88614, 88836, 90220, 91216, 91219, 92004, 92006, 92009, 92596, 92782, 93107, 93329 and 93890. NDC 42023-182-89 covers 2 lots: 84193 and 92880. Expiration dates run from 10/2026 to 09/2027. Lots 83449 and 84193 expire in 10/2026. This was not sold at retail.
Why Was This Product Recalled?
Particulate matter was detected in certain lots. It was identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. Argatroban is a blood thinner given by IV to adults with heparin-induced thrombocytopenia, including some undergoing a heart procedure called PCI. The company says giving contaminated product has a reasonable probability of causing life-threatening health consequences, including pulmonary emboli, blood vessel blockages that can lead to tissue death and possible organ damage, and inflammation of vein walls that may lead to clotting. Par reports no adverse events to date. No recall classification was given in the sources.
What Should You Do?
This is a hospital-administered drug, so there is nothing for consumers to pull from a shelf. Patients with questions should talk to their care team or hospital pharmacy. Wholesalers and hospital pharmacies should stop use and distribution immediately and notify any accounts they supplied. Par is sending written notice and arranging returns through Inmar. For recall questions, call Inmar at 1-855-648-7909 (Mon-Fri, 9am-5pm ET) or email [email protected]. For medical questions, complaints or adverse events, call Par at 1-800-828-9393. Adverse reactions can also be reported to FDA MedWatch at fda.gov/medwatch.
Source:https://www.fiercepharma.com/pharma/par-health-recalls-22-lots-iv-blood-thinner-its-3rd-recall-month