Diclofenac Sodium, Topical Gel, 3%, 100 g 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 51672-1363-7

Recall Number: D-0342-2026

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Ongoing

Report Date: 20260211

Initiation Date: 20260127

Termination Date:

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

Diclofenac Sodium, Topical Gel, 3%, 100 g 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 51672-1363-7