Argatroban Injection 250 mg/2.5 mL (100 mg/mL)

• Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel
• Company: Par Health USA, LLC
• Drugs
• FDA
• October 13, 2026

Product details

• Argatroban Injection 250 mg/2.5 mL (100 mg/mL)

Company announcement

Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) nationwide due to the presence of particulate matter.

The product was distributed to wholesalers and hospitals between December 30, 2024, and May 5, 2026.

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

Risk:

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 including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting.

Impacted states: Nationwide

Products:

- Argatroban Injection 250 mg/2.5 mL (100 mg/mL)

Contact

For more information, call 1-855-648-7909.

View the original FDA notice

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