FDA-Drug2026-02-11Class IIPROCESSING DEFECT
Sun Pharmaceutical Diclofenac Sodium Topical Gel recalled for viscosity specification failure
What this means
Sun Pharmaceutical is recalling one lot of Diclofenac Sodium Topical Gel, 3% (Lot #AD92721, expiring 3/31/2027) because the gel's thickness is slightly lower than required specifications. The product was distributed nationwide and is sold by prescription only.
- Check your Diclofenac Sodium Gel 3% tube for Lot #AD92721
- Stop using this lot and do not apply it to your skin
- Contact your pharmacy or doctor for a replacement or alternative pain relief medication
- Do not throw the gel in the trash; ask your pharmacy how to dispose of it safely
The agency's original wording
Hazard
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0342-2026More Sun Pharmaceutical recalls
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