PlainRecalls
FDA Drug Critical Not Yet Classified Ongoing

Diclofenac Sodium, Topical Gel, 3%, 100 g, 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.

Reported: February 11, 2026 Initiated: January 27, 2026 #N/A

Product Description

Diclofenac Sodium, Topical Gel, 3%, 100 g, 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

This market withdrawal has been initiated in response to Out of Specification (OOS) results observed in in viscosity for Diclofenac Sodium Gel, 3%.

Details

Units Affected
N/A
Distribution
US Nationwide.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Diclofenac Sodium, Topical Gel, 3%, 100 g, 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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: N/A.
Why was this product recalled?
This market withdrawal has been initiated in response to Out of Specification (OOS) results observed in in viscosity for Diclofenac Sodium Gel, 3%.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 11, 2026. Severity: Critical. Recall number: N/A.