Quality & complianceOfficial

Pfizer's Levoxyl tablets recalled in US over subpotency found in stability testing

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

FDA's enforcement report lists a Class II recall of Pfizer's levothyroxine sodium tablets after an out-of-specification assay result, with distribution across the US and Puerto Rico.

The US Food and Drug Administration has published a Class II recall of Levoxyl (levothyroxine sodium tablets), made by Pfizer, in its enforcement report dated 28 October 2026. The recall carries the number D-0051-2027.

The reason given is subpotency. According to the entry, the problem arose from a confirmed out-of-specification (OOS) assay result obtained during stability testing, meaning the product did not meet its assay specification at the point tested.

The recall covers US nationwide distribution and Puerto Rico. Its status is listed as ongoing, so the action had not been closed when the report was published.

The material available does not include details such as lot numbers, expiry dates, the quantity of product involved, the specific stability time point or the OOS result itself. Those particulars are not stated here and should be checked in the full FDA record.

What it means for your team

  • Quality teams should treat confirmed OOS stability results as a potential trigger for market action, particularly where they indicate subpotency.
  • Regulatory affairs teams handling levothyroxine products should review the full FDA entry for lot and code information, which was not available in the text reviewed.
  • Pharmacovigilance teams may wish to watch for any reports linked to reduced potency of thyroid hormone replacement products, though the source does not report adverse events.
  • The recall is ongoing, so scope and status may change 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.

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