The Food and Drug Administration announced a recall of Levoxyl (levothyroxine sodium tablets, USP) distributed by Pfizer Inc. on September 29, 2026. The recall affects tablets in 175 mcg, 100 tablet bottles and 1000-count bottles, due to a confirmed out-of-specification assay during stability testing.

This recall is classified as Class II, indicating it may cause temporary or reversible health problems, and is ongoing across the US and Puerto Rico. Details can be found in the FDA's weekly enforcement report.

Press Release: Food and Drug Administration

Published October 28, 2026. Reproduced in full from the Food and Drug Administration.

Pfizer drug recall

  • Recalling company: Pfizer
  • Classification: Class II (may cause temporary or reversible health problems)
  • Recall numbers: D-0051-2027, D-0052-2027
  • Status: Ongoing
  • Distribution: US Nationwide and Puerto Rico
  • Recall started: September 29, 2026

What was recalled

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10

Why

Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

This drug recall appears in the FDA's weekly enforcement report. Details: FDA recall event 99963.