Diclofenac Sodium recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling 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: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
What is being recalled
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
Why
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # AD92721, Exp Date: 3/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0342-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 27, 2026 |
| Reported | February 11, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
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