FDA-Drug2026-01-21Class IIICHEMICAL
Taro Pharmaceuticals fluocinolone acetonide topical solution recalled for failed impurity specifications
What this means
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.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Intended for
Adults
Illnesses reported
None reported
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-0256-2026More Sun Pharmaceutical recalls
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