FDA-Drug2026-04-22Class IIPROCESSING DEFECT

Taro Fluocinonide 0.05% Cream recalled for failed viscosity specifications

OTHERNationwide distribution

Stop using Taro Fluocinonide Cream, Lot AD76251

Taro Pharmaceuticals is recalling Fluocinonide 0.05% Cream (30g tubes, Lot AD76251, expiring 6/30/2026) because the product's thickness is outside the acceptable range. This was discovered during stability testing. The thicker-than-normal cream may affect how well it spreads and works on skin.

  • Check your Fluocinonide Cream tube for Lot# AD76251 and expiration date 6/30/2026.
  • Stop using it and contact your pharmacist or doctor for a replacement.
  • Do not flush or throw the cream in the trash; ask your pharmacist how to safely dispose of it.
Hazard

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Sold states
Nationwide in the USA.
Affected count
41,712 30g tubes
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Fluocinonide, USP, 0.05% Cream, 30g 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 51672-1386-2.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0476-2026

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