SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada…

Recall date

January 27, 2026

Source

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

Recall number

D-0342-2026

FDA classification

Class II

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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