Par Health Issues Voluntary Nationwide Recall Of Argatroban Injection Due To The Presence Of Particulate Matter

TL;DR

Before you orderOffer from Amazon

Get workout gear delivered free with Prime

• Fast, free delivery on millions of items
• Prime Video, Amazon Music and more included
• Member-only deals all year

Start your free Prime trial →Free trial for eligible customers · Cancel anytime

As an affiliate, we earn on qualifying purchases.Hide

Par Health USA is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL after particulate matter was detected in certain lots. The company says affected product was distributed nationwide to wholesalers and hospitals from Dec. 30, 2024, through May 5, 2026, and warns that administration could cause life-threatening complications. No adverse events related to the recall had been reported to the company as of its Oct. 13 announcement.

Par Health USA, LLC is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL after particulate matter was detected in certain lots, according to a company announcement posted by the U.S. Food and Drug Administration on Oct. 14. The recall covers product distributed nationwide to wholesalers and hospitals and matters because the company says injecting affected product could cause life-threatening blood-vessel and lung complications.

The recall was announced by Par Health on Oct. 13 and applies to product distributed at the hospital and user level. The FDA said it posted the company’s announcement as a public service and does not endorse the product or company. Par Health said the material detected includes cellulose, polystyrene, polyethylene terephthalate and stopper material, with stainless steel also a possibility.

The affected medicine is labeled Argatroban Injection 250 mg/2.5 mL (100 mg/mL) and may carry the Par Health or Endo USA distributor name. The company listed National Drug Code 42023-182-0183 and lots 4494, 8268, 8671, 8730, 8756, 8775, 8840, 8861, 8883, 9022, 9121, 9122, 9200, 9200, 9200, 9259, 9278, 9310, 9332, 9389, 1931 and 9288. The announcement’s lot table contains repeated lot-number entries; affected purchasers should verify the product against the company’s recall notice and packaging rather than relying on a summarized list.

Par Health said the lots were distributed Dec. 30, 2024, through May 5, 2026. It is notifying wholesale and hospital accounts in writing and arranging returns through Inmar, Inc. The company reported that it had received no reports of adverse events related to the recall as of the announcement. That statement describes reports received by the company, not a determination that no one has been harmed.

Risks for Patients Receiving Argatroban

Argatroban is a direct thrombin inhibitor used to prevent or treat thrombosis in adults with heparin-induced thrombocytopenia, or HIT. It is also used as an anticoagulant for adults with or at risk for HIT who are undergoing percutaneous coronary intervention. A recall of hospital-supplied injectable medicine can affect care because hospitals and pharmacies must identify and remove affected stock while maintaining appropriate treatment for patients who need anticoagulation.

Par Health warned that administration of product containing particulate matter carries a reasonable probability of life-threatening adverse health consequences. The company named pulmonary emboli, blockages of other blood vessels that could lead to tissue death or organ damage, and inflammation of vein walls that may lead to clotting. These are the risks stated in the recall notice; the announcement does not say that these outcomes have occurred in patients tied to the recalled lots.

For patients and caregivers, the immediate practical point is to contact the treating hospital or clinician about any concerns rather than stopping or changing anticoagulant treatment independently. The company’s instructions are directed to wholesalers and hospital pharmacies: affected product should be taken out of use and distribution, and recipients should be notified if the product was passed on to other locations.

How the Recall Reaches Hospitals

The company’s notice identifies a nationwide distribution period spanning nearly 17 months, from late 2024 to May 2026. That window means hospitals and wholesalers may need to check inventory and distribution records, including whether product was transferred to another facility. The recall is described as voluntary and is being conducted with the knowledge of the FDA.

Par Health said the product was distributed under the names Par Pharmaceutical or Endo USA. The announcement explains that Par Pharmaceutical, Inc. and Endo USA, Inc. are predecessor companies to Par Health USA, LLC, the current distributor. The listed presentation is a 250 mg/2.5 mL vial, with a concentration of 100 mg/mL.

The FDA’s posting is a company announcement, not an agency statement endorsing the product or independently characterizing the recall. The company’s notice supplies the reason, affected product identifiers, risk description and return instructions. The FDA also directs people who experience adverse reactions or quality problems to its MedWatch reporting program.

“Administration of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences.”

— Par Health, in its October 13 recall announcement

Questions About Exposure and Lot Records

The announcement does not identify how many vials or patients may be affected, how many units remain in circulation, or the specific locations that received each lot. It also does not provide details about how the particulate matter entered the product or whether the company has determined a single source. The materials are identified as cellulose, polystyrene, polyethylene terephthalate and stopper material, with stainless steel listed as possible.

Par Health said it had received no adverse-event reports related to the recall by Oct. 13. The notice does not give a separate estimate of patient exposure or a complete account of reports made to hospitals, regulators or other parties. The published lot table also contains repeated lot numbers, so readers should consult the original recall notice, package label and distributor guidance to confirm an exact match.

The announcement does not state whether the recall will be expanded, whether additional testing is under way, or when the return process will be complete. Those details may change as the company contacts accounts and gathers information.

Hospitals Must Check and Return Stock

Wholesale distributors and hospital pharmacies holding affected product should immediately discontinue use and stop distribution, according to Par Health. If a recipient distributed the product further, the company says it should notify the accounts or additional locations that may have received it. Par Health is coordinating returns of existing inventory through Inmar.

Questions about the recall can be directed to Inmar at 1-855-648-7909, Monday through Friday, 9 a.m. to 5 p.m. Eastern time, or by email at rxrecalls@inmar.com. For medical or technical product information, or to report a product complaint or adverse event to Par Health, the notice lists 1-800-828-9393, available Monday through Thursday from 9 a.m. to 8 p.m. Eastern and Friday from 9 a.m. to 6 p.m.

Adverse reactions or quality problems may also be reported to the FDA through MedWatch, online, by mail or by fax. The next developments will depend on the company’s account notifications, return process and any further information it or the FDA provides about the affected lots and investigation.

Key Questions

Which argatroban product is being recalled?

The recall covers Argatroban Injection 250 mg/2.5 mL (100 mg/mL) in 22 listed lots, distributed under Par Health or Endo USA labeling. Check the vial and the original company notice to verify the lot and NDC.

Why did Par Health issue the recall?

Par Health said particulate matter was detected in certain lots. The company identified cellulose, polystyrene, polyethylene terephthalate and stopper material, with stainless steel also possible.

What should hospitals and wholesalers do?

The company instructed wholesalers and hospital pharmacies to stop using and distributing affected product immediately, notify any further recipients and arrange returns through Inmar, Inc.

Have adverse events been reported?

Par Health said it had received no reports of adverse events related to the recall as of Oct. 13, 2026. The announcement does not provide a separate estimate of patient exposure.

How can a recall question or adverse event be reported?

Recall questions can be directed to Inmar at 1-855-648-7909 or rxrecalls@inmar.com. Par Health lists 1-800-828-9393 for product information, complaints or adverse events; adverse reactions or quality problems may also be reported through the FDA’s MedWatch program.

Source: primary