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FDA Recalls · October 13, 2026 · Primary source

Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter

Score 40PRIMARYregulatoryFDA

Summary

Par Health is conducting a voluntary nationwide recall of 22 lots of Argatroban Injection 250 mg/2.5 mL to the hospital and user level due to the presence of particulate matter identified as cellulose, polystyrene, and polyethylene terephthalate. The recall was announced October 13, 2026, and is being coordinated with FDA. Argatroban is an anticoagulant used in hospital settings, including for heparin-induced thrombocytopenia.

What this may mean

Hospitals and other facilities holding affected lots of Argatroban Injection face immediate supply disruption and must quarantine recalled product. The recall reaches the hospital and user level, meaning facilities must identify and segregate affected lots. No billing, coding, or reimbursement rule change accompanies the recall.

Informational only. Not legal, medical, financial, or other professional advice. Always consult a qualified professional familiar with your specific facts before relying on any item.

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