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

Recall Number: D-0256-2026

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class III

Status: Ongoing

Report Date: 20260121

Initiation Date: 20251230

Termination Date:

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

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