FDAFDA · Food and drugs·Recall number D-0342-2026
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
Published February 11, 2026 · Recall initiated: January 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DICLOFENAC SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- US Nationwide.
- Lot
- Lot # AD92721, Exp Date: 3/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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