Quality & complianceOfficial

FDA lists Class II recall of phenylephrine infusion over sterility assurance concerns

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

Eagle Pharma Outsourcing LLC's phenylephrine HCl infusion is subject to an ongoing nationwide US recall, classified for lack of assurance of sterility.

The US Food and Drug Administration has published a Class II recall of PHENYLephrine HCl infusion made by Eagle Pharma Outsourcing LLC in its enforcement report dated 4 November 2026. The recall number is D-0105-2027.

The stated reason for the recall is lack of assurance of sterility. The FDA lists the recall as ongoing, and the product was distributed nationwide within the United States.

The entry available to VigiEye does not give details such as strengths, presentations, lot numbers, expiry dates, quantities or the date the firm began the recall. Nor does it say whether any adverse events have been reported.

For context, the FDA assigns Class II to recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse consequences is remote.

What it means for your team

  • Hospital pharmacy, wholesale and distribution teams in the US should check the full FDA enforcement report entry for recall D-0105-2027 to confirm affected lots and recall instructions.
  • Quality teams should review supplier qualification and sterility-assurance controls for compounded or outsourced sterile injectables, where relevant.
  • Pharmacovigilance teams may want to ensure any product quality complaints or infection-related reports linked to this product are captured and escalated.

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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