Moderate riskFDA DrugClass II

Sun Pharmaceutical fluocinonide cream recalled for viscosity issue

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.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
41,712 30g tubes
Illnesses reported
None reported
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Classification
Class II
Recall number
D-0476-2026

In the FDA's words

Description
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. Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Lot# AD76251, Exp Date: 6/30/2026. Distribution: Nationwide in the USA. Affected quantity: 41,712 30g tubes
Hazard
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

3 products in this recall

The agency lists each product separately. Check every one you might have.

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