Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1

Recall Number: D-0475-2026

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Ongoing

Report Date: 20260422

Initiation Date: 20260325

Termination Date:

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1