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

FDA recall notice · announced January 21, 2026 · Sun Pharmaceutical Industries

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the USA
Lot/code information: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Quantity: 24,624 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0256-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.