Anticoagulant recalled over life-threatening risk

Contamination in 22 lots of the injection may cause pulmonary embolism or vascular occlusion; no related adverse events reported.

By
Mouj Hijazi
October 15, 2026
3 min

MDSpire News

At a Glance

Category	Detail
Condition	Clinical topic addressed by the source article: Anticoagulant recalled over life-threatening risk
Key Mechanisms	Mechanisms or clinical associations described in the source article.
Target Population	Patients or participants described in the source article.
Care Setting	Products were distributed to wholesalers and hospitals across the United States; the recall extends to the hospital and user level.

Key Highlights

Par Health USA voluntarily recalled 22 lots of argatroban injection, 250 mg/2.5 mL (100 mg/mL), distributed under the Par Health and Endo USA names.
The recall covers NDC 42023-182-01 (20 lots) and NDC 42023-182-89 (2 lots); affected expiration dates range from October 2026 through September 2027.
The FDA-published company announcement identified cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel particles.
The company reported no adverse events associated with the recalled products as of its October 13 announcement.
The recall is limited to the specified lots, not all argatroban injection products.

Guideline-Based Recommendations

Diagnosis

Identify whether a product is affected by checking its name, NDC, and lot number against the recall details.
For patients who may have received an affected product, assess for signs or symptoms of pulmonary embolism, vascular occlusion, tissue or organ injury, or venous inflammation and clot formation.

Management

Immediately stop using and distributing affected lots; do not use recalled product.
Facilities that redistributed affected lots should notify downstream accounts and locations that may have received them.
Contact Par Health for questions about the recall and report suspected adverse events or product quality problems to FDA MedWatch or Par Health.

Monitoring & Follow-up

Monitor patients exposed to affected product for potential serious vascular complications, including pulmonary emboli, occlusion of other blood vessels, tissue death or organ damage, and venous inflammation that may lead to clot formation.
Report suspected adverse events and product quality problems through FDA MedWatch or to Par Health.

Risks

Par Health warned that administration of affected injections has a reasonable probability of causing serious adverse health consequences, including pulmonary emboli, occlusion of other blood vessels potentially resulting in tissue death or organ damage, and inflammation of venous walls that may lead to clot formation.

Patient & Prescribing Data

Argatroban is indicated for prophylaxis or treatment of thrombosis in adults with HIT and for anticoagulation in adults with or at risk for HIT undergoing percutaneous coronary intervention.

Argatroban is a direct thrombin inhibitor. The recall concerns specified contaminated lots distributed to wholesalers and hospitals in the United States between December 30, 2024, and May 5, 2026.

Clinical Best Practices

Check product name, NDC, and lot against the recall details before use or distribution.
Immediately discontinue use and distribution of affected lots. Facilities that redistributed affected lots should notify downstream accounts and locations that may have received them.
Report suspected adverse events or product quality problems through FDA MedWatch or to Par Health.

Related Resources & Content

Par Health USA. Voluntary nationwide recall of argatroban injection due to particulate matter. FDA, October 14, 2026.
US Food and Drug Administration. Argatroban injection: prescribing information. Revised 2026.