SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc…

Recall date

December 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0256-2026

FDA classification

Class III

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

Nationwide within the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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