Quality & complianceOfficial

FDA lists Class II recall of Eagle Pharma Outsourcing oxytocin over lack of sterility assurance

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The recall, numbered D-0106-2027 and still ongoing, covers oxytocin distributed nationwide within the United States, according to the FDA enforcement report.

The US Food and Drug Administration has recorded a Class II recall of oxytocin from Eagle Pharma Outsourcing LLC in its enforcement report dated 4 November 2026. The recall carries the number D-0106-2027.

The stated reason is a lack of assurance of sterility. The record gives the status of the recall as ongoing, meaning the action had not been closed at the time of the report.

According to the entry, the product was distributed nationwide within the US. The material available to VigiEye does not include product strengths, presentation, lot numbers, expiry dates, quantities or the date the firm began the recall, so the scale of the affected supply cannot be assessed from this information.

For context, the FDA applies a Class II designation where use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Hospital pharmacy and supply-chain teams should check the full FDA enforcement report entry for lot and presentation details and compare it against any oxytocin held in stock.
  • Quality teams at outsourcing facilities and their customers may wish to review sterility assurance controls and supplier qualification records in light of the stated recall reason.
  • Pharmacovigilance teams should note that the recall is ongoing and that further details, including any change in status, may appear in later enforcement reports.

Official source: FDA enforcement report ↗

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

More Quality & compliance All →