SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.
Recalled January 21, 2026 · FDA recall D-0256-2026 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. · FDA Class III
Units
24,624 bottles
Sold at
Nationwide within the USA
Description
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
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
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →