Taro Diclofenac Sodium Topical Gel 3%
Diclofenac Sodium Topical Gel 3% has a viscosity that is slightly lower than the limit.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
SUN PHARMACEUTICAL INDUSTRIES INC of Princeton, New Jersey began a recall on January 27, 2026, of Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, distributed nationwide.
The product, manufactured by Taro Pharmaceuticals Inc. of Brampton, Ontario, Canada, and distributed by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, failed viscosity specifications with an out of specification result slightly lower than the limit.
The FDA added the recall to its Enforcement Report on February 5, 2026, and it was in the weekly report on February 11, 2026, with classification on February 23, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your tube affected?
Match the NDC and lot code listed under your product.
Diclofenac Sodium, Topical Gel, 3%, 100 g tube
- NDC
- 51672-1363-7
- Lot
- AD92721
Details
- Company began the recall
- Sold in
US Nationwide.
- Event ID
- 98351
- Recall No.
- D-0342-2026
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Failed specifications
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
