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Medium risk Drugs & MedicationsClass II

Taro Fluocinonide Cream 0.05% Recall

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Phar

Updated March 25, 2026

Fluocinonide 0.05% Cream (30g tube) is being recalled because the cream's viscosity (thickness) tested above safe limits during quality testing. This may affect how the medication spreads and absorbs on skin.

Is the SUN PHARMACEUTICAL INDUSTRIES INC recalled? Yes. This product was recalled by FDA on March 25, 2026. Details below.

What is recalled

Fluocinonide, USP, 0.05% Cream, 30g tube, prescription only. Manufactured by Taro Pharmaceuticals Inc. (Brampton, Ontario, Canada), distributed by Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY). NDC number: 51672-1386-2.

Am I affected

You're affected if you have a prescription bottle of Fluocinonide 0.05% Cream in a 30g tube with NDC number 51672-1386-2.

What to do right now

Contact your pharmacy or prescriber about this recall. Do not use the remaining cream until you speak with your healthcare provider or pharmacist about whether you should continue or get a replacement.

The hazard

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

Brands affected

SUN PHARMACEUTICAL INDUSTRIES INC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0476-2026
Classification
Class II
Recalled
March 25, 2026
Read the official notice

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