22 Lots of Par Health Argatroban Injection Recalled Nationwide in 2026

Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) across the United States after particulate matter was detected in certain lots. The recall goes to the hospital and user level. The company announced it on October 13, 2026, and the FDA posted the notice on October 14, 2026.

The particulate matter has been identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The lots were distributed nationwide to wholesalers and hospitals between December 30, 2024, and May 5, 2026.

Quick Facts

• Company: Par Health USA, LLC (brands: Par Health and Endo USA)
• Product: Argatroban Injection 250 mg/2.5 mL (100 mg/mL)
• Lots recalled: 22
• NDC numbers: 42023-182-01 and 42023-182-89
• Distribution window: December 30, 2024, to May 5, 2026
• Recall level: Hospital/user level, nationwide

Products Affected by This Recall

The recall covers Argatroban Injection 250 mg/2.5 mL (100 mg/mL), distributed by Par Pharmaceutical or Endo USA. Both are predecessor companies to Par Health USA, LLC, the current distributor of the product.

Under NDC 42023-182-01, the affected lots and expiration dates are:

• Lot 83449, expires 10/2026
• Lot 82682, expires 11/2026
• Lots 86714, 87302 and 87560, expire 02/2027
• Lots 87753 and 88401, expire 03/2027
• Lots 88614 and 88836, expire 04/2027
• Lot 90220, expires 05/2027
• Lots 91216 and 91219, expire 06/2027
• Lots 92004 and 92006, expire 07/2027
• Lots 92009, 92596, 92782, 93107 and 93329, expire 08/2027
• Lot 93890, expires 09/2027

Under NDC 42023-182-89, two lots are affected: lot 84193, which expires 10/2026, and lot 92880, which expires 08/2027.

What Triggered the Recall

Particulate matter was detected in certain lots of the injection. The announcement lists the materials found as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.

Par Health states that administering Argatroban Injection containing particulate matter has a reasonable probability of causing life-threatening adverse health consequences. These include pulmonary emboli, which are blockages in pulmonary blood vessels. They also include occlusions of other blood vessels, which can lead to tissue death and possible organ damage, and inflammation of the walls of veins, which may lead to clotting.

To date, Par Health has not received any reports of adverse events related to this recall.

Who Should Be Concerned

Argatroban Injection is a direct thrombin inhibitor. It is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). It is also used as an anticoagulant in adult patients with or at risk for HIT who are undergoing percutaneous coronary intervention.

The product is distributed through wholesalers and hospitals rather than sold to the general public. The accounts most directly affected are therefore wholesale distributors and hospital pharmacies that received the listed lots. Patients who are being treated with argatroban in a hospital setting and have questions should raise them with their care team.

How to Respond to This Recall

Par Health is sending written notification to wholesale and hospital accounts that received the affected lots. It is arranging the return of all existing inventory through Inmar, Inc.

• Wholesale distributors and hospital pharmacies holding the recalled lots should immediately discontinue use and stop distribution.
• Anyone who has further distributed the recalled product should notify their accounts or any additional locations that may have received it.
• Check inventory against the NDC numbers, lot numbers and expiration dates listed above.
• Questions about the recall can go to Inmar, Inc. at 1-855-648-7909, Monday through Friday, 9 a.m. to 5 p.m. ET, or by email at rxrecalls@inmar.com.
• For medical or technical product information, or to report a product complaint or adverse event, call Par Health at 1-800-828-9393. Lines are open Monday through Thursday from 9 a.m. to 8 p.m. ET and Friday from 9 a.m. to 6 p.m. ET.

Adverse reactions or quality problems linked to the product may also be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be filed online, by regular mail or by fax.

What the Company Said

In its announcement, Par Health said the recall is a voluntary nationwide action carried out to the hospital and user level. The company said the recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Media inquiries can be directed to Gena Holthaus, Senior Director, Corporate Brand and Communications, at media.relations@parhealth.com.

The FDA notes that it posts company announcements as a public service and does not endorse either the product or the company.