FDA-Drug2026-02-11Class IIPROCESSING DEFECT
Sun Pharmaceutical Diclofenac Sodium Topical Gel recalled for viscosity specification failure
OTHERNationwide distribution
Stop using Sun Pharmaceutical Diclofenac Sodium Gel
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
Hazard
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
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 INDUSTRIES INC recalls
- FDA-Drug2026-06-17Sun Pharmaceutical budesonide inhalation suspension recalled for foreign particles
- FDA-Drug2026-06-17Sun Pharmaceutical doxorubicin injection recalled for glass particles
- FDA-Drug2026-04-22Taro Fluocinonide 0.05% Cream recalled for failed viscosity specifications
- FDA-Drug2026-04-22Taro Pharmaceuticals fluocinonide cream recalled for failed viscosity specifications
- FDA-Drug2026-04-22Taro Pharmaceuticals fluocinonide 0.05% cream recalled for viscosity defect
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief