Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Bram...
FDA Recall #D-0342-2026 — Class II — January 27, 2026
Product Description
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
Reason for Recall
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
US Nationwide.
Code Information
Lot # AD92721, Exp Date: 3/31/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated