FDA-Drug2026-01-21Class IIICHEMICAL

Taro Pharmaceuticals fluocinolone acetonide topical solution recalled for failed impurity specifications

OTHERNationwide distribution

Stop using recalled fluocinolone acetonide solution

Taro Pharmaceuticals is recalling specific lots of fluocinolone acetonide topical solution (0.01%) because testing found higher-than-allowed levels of an impurity. The affected lots were distributed nationwide. No injuries have been reported.

  • Check your fluocinolone acetonide bottle for lot number AD81290, AD81291, AD81292, or AD81293 with expiration date 1/31/2027.
  • Stop using the medication if your bottle matches these lot numbers.
  • Contact your pharmacy or doctor for a replacement or alternative treatment.
  • Do not flush the medication down the toilet; ask your pharmacy how to dispose of it safely.
Hazard

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

Sold states
Nationwide within the USA
Affected count
24,624 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0256-2026

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