Moderate riskFDA DrugApr 22, 2026Class II

Sun Pharmaceutical fluocinonide cream recalled for viscosity failure

Taro Pharmaceuticals is recalling one lot of fluocinonide 0.05% cream due to viscosity testing that showed the cream is thicker than the approved specification. This may affect how the medication spreads and absorbs. No injuries have been reported.

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

What to do

Check if you have lot #AD76250 with expiration date 6/30/2026 (NDC 51672-1386-3)
If you have this lot, stop using it and contact your pharmacy or doctor
Your pharmacist can provide a replacement or alternative

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Fluocinonide, USP, 0.05% Cream, 60g 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 51672-1386-3.
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 2,640 60g tubes
Illnesses reported: None reported
Manufactured in: 2 Independence Way, N/A, Princeton, NJ, United States
Classification: Class II
Recall number: D-0477-2026

In the FDA's words

Description: Fluocinonide, USP, 0.05% Cream, 60g 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 51672-1386-3. Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Lot# AD76250, Exp Date: 6/30/2026. Distribution: Nationwide in the USA. Affected quantity: 2,640 60g 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.

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A…
D-0475-2026 · 24,672 15 g tubes
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…
D-0476-2026 · 41,712 30g tubes
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A… (this page)
D-0477-2026 · 2,640 60g tubes