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Health & beauty United States Recall (ongoing)

Sun Pharmaceutical Industries Inc recalls Fluocinonide and 2 more products

Fluocinonide, USP 0.05% cream in 15 g (NDC 51672-1386-1), 30 g (NDC 51672-1386-2) and 60 g (NDC 51672-1386-3) tubes, distributed by Taro Pharmaceuticals U.S.A., Inc., are being recalled by Sun Pharmaceutical Industries Inc; affected lots are AD76252, AD76251 and AD76250, all expiring 6/30/2026, sold nationwide in the United States. The recall was initiated after stability testing showed out-of-specification viscosity results above the specification limit.

What's being recalled

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., Inc., Hawthorne, NY 10532, NDC 51672-1386-1

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.

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.

Recalling firm: Sun Pharmaceutical Industries Inc, Princeton, NJ, United States.

How to identify it

Lot# AD76252, Exp Date: 6/30/2026. Lot# AD76251, Exp Date: 6/30/2026. Lot# AD76250, Exp Date: 6/30/2026.

The hazard

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

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

Nationwide in the USA.

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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