SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium
- Recalling company
- SUN PHARMACEUTICAL INDUSTRIES INC
- 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
- Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 27, 2026
- Reported
- Feb 11, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot # AD92721, Exp Date: 3/31/2027.
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0342-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0342-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.