Recall: D-0342-2026

Class II - Potentially Harmful

Class IIClassification

2026-01-27Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

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

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.