Data Composite

Recall D-0342-2026

US Class II Ongoing · initiated 2026-01-27

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC, NJ

Product

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%.

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