Sun Pharmaceutical recalls Fluocinolone Acetonide topical solution over failed impurity test
A test of the 0.01% topical solution in 60-mL bottles found more of a known impurity, called impurity D, than allowed, so the product failed its quality limits.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall details
- Product
- 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
- Hazard
- Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- Units
- 24,624 bottles
- Where sold
- Nationwide within the USA
- FDA classification
- Class III · Ongoing
- Classified by FDA
- January 13, 2026
- Recall started
- December 30, 2025
- FDA enforcement report
- January 21, 2026
- Identifiers
- Codes: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
- FDA recall number: D-0256-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide within the USA
- Quantity
- 24,624 bottles
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