Par Health Recalls 22 Lot Numbers of Argatroban Injection Following Detection of Particulate Contaminants

Recall Overview

Par Health USA announced a nationwide recall of 22 lot numbers of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) after particulate matter was detected in several batches. The FDA posted the company’s notice, which identified the contaminants as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The recall was issued on October 13 2026 and applies to the hospital and user level.

Argatroban is an intravenous anticoagulant administered in hospital settings. It is employed to prevent or treat thromboembolic events in patients with heparin‑induced thrombocytopenia (HIT), an immune‑mediated reaction to the commonly used blood thinner heparin. The drug is also indicated for anticoagulation in adults with or at risk for HIT undergoing percutaneous coronary intervention, a procedure that restores blood flow through narrowed coronary arteries.

The recalled lots were distributed to wholesalers and hospitals across the United States between December 30 2024 and May 5 2026. Because patients do not purchase or store argatroban at home, responsibility for removal lies with hospital pharmacies and distribution partners.

The 22 Lots Pharmacies Need to Find

Twenty of the recalled batches share NDC 42023‑182‑01. The lot numbers and expiration months are: 83449 (10/2026), 82682 (11/2026), 86714, 87302, 87560 (02/2027), 87753, 88401 (03/2027), 88614, 88836 (04/2027). Additional 42023‑182‑01 lots include 90220 (05/2027), 91216 & 91219 (06/2027), 92004 & 92006 (07/2027), 92009, 92596, 92782, 93107, 93329 (08/2027), and 93890 (09/2027). Two other lots have NDC 42023‑182‑89: lot 84193 (10/2026) and lot 92880 (08/2027). The labeling indicates prior distributors Par Pharmaceutical or Endo USA, now subsidiaries of Par Health USA.

Why Particles in This Drug Are a Concern

The recall notice states that use of the compromised product “has a reasonable probability of causing life‑threatening adverse health consequences.” Potential complications include pulmonary emboli, vascular occlusions, and phlebitis. Since argatroban is administered intravenously, any particulate contaminant enters the bloodstream directly.

Patients with heparin‑induced thrombocytopenia (HIT) are especially vulnerable. HIT is an immune‑mediated condition where heparin exposure causes thrombocytopenia and simultaneously heightens the risk of severe clot formation. Management involves discontinuing heparin and transitioning to an alternative anticoagulant; argatroban is a preferred agent for critically ill patients or those at heightened bleeding risk. This population already faces an elevated thrombotic threat.

To date, no adverse events have been reported in connection with this recall. Par Health indicated that it “has not received any reports of adverse events related to this recall.”

Particle‑related recalls of injectable medications have been a recurring issue throughout 2026, highlighted by an American Regent recall involving glass fragments. Argatroban has experienced previous particle contamination incidents; in December 2011, Eagle Pharmaceuticals withdrew four lots of a 50 mg/50 mL argatroban formulation after visible particles were detected, as documented in the Drugs.com FDA alerts archive.

What Hospitals and Families Should Do

Patients cannot inspect the vials themselves. However, family members who know that a relative received argatroban during a hospital admission since late December 2024 can inquire with the care team about whether the facility holds any of the recalled lots.

Warning signs that merit immediate medical evaluation include sudden shortness of breath, chest pain, new arm or leg pain/swelling, and redness, swelling, or discomfort at the IV site. Acute dyspnea or chest pain should trigger emergency care. These manifestations are nonspecific and do not automatically indicate exposure to the recalled product.

Healthcare providers and patients may report suspected adverse events or product quality concerns to the FDA’s MedWatch program. Par Health’s customer service line for medical inquiries and product complaints is 1‑800‑828‑9393, available Monday–Thursday 9 a.m.–8 p.m. ET and Friday 9 a.m.–6 p.m. ET.

The recall notice leaves several details unresolved. It does not specify how the contamination was discovered, the root cause, the total number of vials involved, or whether the particles were visually apparent. Supply chain implications are also unaddressed, and the notice lacks a formal FDA recall classification. Such a classification, if assigned, will be posted in the FDA’s recalls, market withdrawals, and safety alerts database.

Hospitals must locate and dispose of all compromised vials while ensuring that patients requiring anticoagulation for HIT receive an appropriate substitute without interruption of therapy.

Key Questions Answered

What is being recalled? Par Health USA is recalling 22 lot numbers of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) bearing NDCs 42023‑182‑01 and 42023‑182‑89, with expiration dates ranging from October 2026 through September 2027.

Why was it recalled? The recall was triggered after particulate contaminants—including cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel—were identified in specific batches.

Has anyone been hurt? According to Par Health, no adverse‑event reports have been received in connection with this recall.

Do patients need to do anything? No in‑home actions are required because argatroban is administered only in hospital settings. Families with concerns about a recent inpatient stay should consult the care team.

What symptoms should people watch for? Watch for sudden shortness of breath, chest pain, new arm or leg swelling/pain, and redness, swelling, or discomfort at an IV site. Acute dyspnea or chest pain should prompt immediate emergency care.

Who should hospitals contact? Inmar, Inc. coordinates recall inquiries and product returns and can be reached at 1‑855‑648‑7909. For medical questions or product complaints, contact Par Health at 1‑800‑828‑9393.

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