Sun Pharmaceutical recalls Diclofenac Sodium 3% topical gel because it is slightly thinner than required
A test found the gel's viscosity (how thick it is) came out slightly lower than the allowed limit, so the 100 g tubes did not meet the required specifications.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Hazard
- Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- Units
- N/A
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- February 23, 2026
- Recall started
- January 27, 2026
- FDA enforcement report
- February 11, 2026
- Identifiers
- Codes: Lot # AD92721, Exp Date: 3/31/2027.
- FDA recall number: D-0342-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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%.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- N/A
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