Warning
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0342-2026Drug / Pharmaceutical
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd
SUN PHARMACEUTICAL INDUSTRIES INC · Class II — Moderate Risk
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%.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from SUN PHARMACEUTICAL INDUSTRIES INC, initiated on January 27, 2026. Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. The product was distributed in US Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.