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Drug FDA Class II Ongoing Failed specifications

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

SUN PHARMACEUTICAL INDUSTRIES INC Published Feb 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Viscosity Specification · primary

Affected products (1)

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

DICLOFENAC SODIUM · N/A

NDC: 51672-1363, 51672-1363-3, 51672-1363-7
Lot codes: AD92721
Code info: Lot # AD92721, Exp Date: 3/31/2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 27, 2026
  2. Published
    Feb 11, 2026
Recall number
D-0342-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.