Quality & complianceOfficial

FDA lists Class I recall of Par Health argatroban injection over particulate matter

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

Par Health USA's argatroban injection is subject to an ongoing nationwide US recall, number D-0083-2027, after particulate matter was identified in the product solution.

The US Food and Drug Administration has published a Class I recall of Argatroban Injection from Par Health USA, LLC in its enforcement report dated 28 October 2026. The recall is numbered D-0083-2027.

The reason given is particulate matter in the product solution. The particles were identified as cellulose, polystyrene, polyethylene terephthalate, stainless steel or stopper material.

The recall status is listed as ongoing, and distribution covered the whole of the United States. The page text available to us does not give lot numbers, expiry dates, quantities or the date the recall began, so affected batches cannot be identified from this item alone.

Under FDA's classification system, Class I is the most serious category. It is used where there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

What it means for your team

  • US hospital pharmacy and supply-chain teams should consult the full FDA enforcement report entry for lot and code details, as these are not in the material reviewed here.
  • Quality teams handling injectables may wish to review particulate and container-closure controls, given the mix of particle types cited, including stopper material.
  • Pharmacovigilance teams may want to check for any adverse event reports linked to argatroban injection from the affected supplier.
  • The recall remains ongoing, so its scope and status could change.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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