FDA Recall: Par Health and Endo USA Argatroban Injection 250 mg/2.5
Source: FDA
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FDA Recall: Par Health and Endo USA Argatroban Injection 250 mg/2.5

Par Health and Endo USA • October 14, 2026

Par Health Argatroban Injection Recall for Particulate Contamination (FDA Alert)

Urgent notice for hospitals and infusion clinics: Par Health USA, LLC has voluntarily recalled 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) after visible and microscopic particles—cellulose, plastics, rubber-stopper fragments, and possibly stainless steel—were detected in certain vials. Administering contaminated Argatroban can cause life-threatening blood-vessel blockages. Cease use or distribution of every lot listed below and start the return process immediately.

Par Health Argatroban Recall at a Glance

  • Recall initiated: October 13, 2026 (FDA posting 10/14/2026)
  • Product category: Prescription intravenous anticoagulant
  • Label names: Par Health and Endo USA
  • Reason for recall: Particulate matter in solution
  • Distribution window: December 30 2024 – May 5 2026 (nationwide)
  • Required action: Quarantine stock, stop use/distribution, and return via Inmar, Inc.
  • Return support: 1-855-648-7909 • rxrecalls@inmar.com

Sources

Lot Numbers and Expiration Dates

Verify the National Drug Code (NDC) and lot number printed on the carton or immediate container:

  • NDC 42023-182-01 — Lots 83449 (10/26), 82682 (11/26), 86714 (02/27), 87302 (02/27), 87560 (02/27), 87753 (03/27), 88401 (03/27), 88614 (04/27), 88836 (04/27), 90220 (05/27), 91216 (06/27), 91219 (06/27), 92004 (07/27), 92006 (07/27), 92009 (08/27), 92596 (08/27), 92782 (08/27), 93107 (08/27), 93329 (08/27), 93890 (09/27)
  • NDC 42023-182-89 — Lots 84193 (10/26) and 92880 (08/27)

Health Risks of Contaminated Argatroban Injection

Injecting a solution that contains foreign particles can result in:

  • Pulmonary embolism (blocked arteries in the lungs)
  • Occlusion of peripheral or central blood vessels, risking tissue or organ loss
  • Vein inflammation (phlebitis) that may promote additional clotting

No injuries have been reported so far, but the FDA classifies this recall as Class I—the most serious—because of the probability of severe harm or death.

Immediate Actions for Hospitals and Distributors

  1. Identify, segregate, and quarantine all recalled lots.
  2. Discontinue use and halt further distribution.
  3. Contact Inmar, Inc. for return instructions and credit.
  4. Alert downstream facilities, departments, and staff that may hold inventory.
  5. Report any adverse events to FDA MedWatch:
    MedWatch Online Form • 1-800-332-1088

Official Product Images

Par Health Argatroban Injection 250 mg/2.5 mL vial label
Source: FDA
Par Health Argatroban Injection vial label alternate view
Source: FDA

Frequently Asked Questions

1. Why was Par Health Argatroban Injection recalled?
Quality testing revealed particulate contamination—including cellulose, plastic, rubber stopper fragments, and possible stainless steel—that can cause embolism or vessel occlusion.
2. Which Par Health Argatroban Injection lots are affected?
Twenty-two lots associated with NDCs 42023-182-01 and 42023-182-89 distributed between 12/30/2024 and 05/05/2026. The complete list appears above.
3. Can we keep Par Health Argatroban vials that look clear?
No. Microscopic particles may be present even if the solution appears clear. All recalled lots must be removed from service.
4. How do we return Par Health Argatroban Injection and obtain reimbursement?
Call Inmar, Inc. at 1-855-648-7909 or email rxrecalls@inmar.com for prepaid shipping labels and credit instructions.
5. Has anyone been injured by Par Health Argatroban Injection to date?
No adverse-event reports have been received, but facilities must still report any issues to FDA MedWatch.
6. Is Par Health Argatroban equivalent to argatroban from other manufacturers?
Yes, all argatroban products contain the same active ingredient, but only Par Health-labeled lots listed in this recall are affected.
7. When will Par Health Argatroban Injection return to the market?
Par Health has not announced a relaunch date. Availability will depend on completion of the investigation and FDA clearance of new, compliant batches.

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