Recalls / Class II
Class IID-0342-2026
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
- Brand name
- Diclofenac Sodium
- Generic name
- Diclofenac Sodium
- Active ingredient
- Diclofenac Sodium
- Route
- Topical
- NDC
- 51672-1363
- FDA application
- ANDA206298
- Affected lot / code info
- Lot # AD92721, Exp Date: 3/31/2027.
Why it was recalled
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2026-01-27
- FDA classified
- 2026-02-23
- Posted by FDA
- 2026-02-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0342-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.