ANNOUNCED ONGOING Drug recall · Reported 14 Oct 2026 · FDA company announcement, classification pending
Par Health and Endo USA Argatroban Injection 250 mg/ (100 mg/mL) recalled
Par Health USA is recalling Par Health and Endo USA Argatroban Injection 250 mg/ (100 mg/mL), distributed nationwide in the US. The recall was initiated on 13 Oct 2026 and is listed as ongoing.
Recall details
- Recall number
- FDA-PR-925572929be7
- Recalling firm
- Par Health USA
- Classification
- Pending
- Status
- Ongoing
- Recall initiated
- 13 Oct 2026
- Reported
- 14 Oct 2026
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Oct 2026 | Recall initiated by company | |
| 14 Oct 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, that was detected in certain lots. 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. To date, Par Health has not received any reports of adverse events related to this recall. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention. Recalled product can be identified as follows and by representative labels at bottom of this document: Product Description NDC Lot Expiration Date Argatroban Injection 250 mg/2.5 mL (100 mg/mL), Distributed by: Par Pharmaceutical* or Endo USA* 42023-182-01 83449 10/2026 82682 11/2026 86714 02/
Product as listed by the company
Par Health and Endo USA Argatroban Injection 250 mg/2.5 mL (100 mg/mL)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, that was detected in certain lots. 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. To date, Par Health has not received any reports of adverse events related to this recall. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention. Recalled product can be identified as follows and by representative labels at bottom of this document: Product Description NDC Lot Expiration Date Argatroban Injection 250 mg/2.5 mL (100 mg/mL), Distributed by: Par Pharmaceutical* or Endo USA* 42023-182-01 83449 10/2026 82682 11/2026 86714 02/
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does an unclassified recall mean?
The FDA assigns a class once it has assessed the health risk. Until then the recall is listed without one.
Read the official FDA notice · Source record retrieved 14 Oct 2026. This is a company announcement published by the FDA; the FDA has not yet classified the recall. The record is updated when the classification appears in the Enforcement Report. This page reports the record and gives no medical advice.
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