HIGH

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...

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

Quick Facts at a Glance

Recall Date
March 25, 2026
Hazard Level
HIGH
Brands
FLUOCINONIDE, Sun Pharmaceutical Industries, Inc.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter

Get instant alerts for FLUOCINONIDE recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Full 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.. Generic: FLUOCINONIDE; Brand: FLUOCINONIDE. Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.. Classification: Class II. Quantity: 41,712 30g tubes. Distribution: Nationwide in the USA.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

Want to Know First?

Get instant alerts for recalls that affect you. Free forever.

Product Classification

Product Details

Model Numbers
Lot# AD76251
Exp Date: 6/30/2026.
UPC Codes
51672-1386
51672-1386-1
51672-1386-2
+2 more
Affected States
ALL
Report Date
April 22, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Sun Pharmaceutical Fluocinolone Acetonide Topical Solution Recall 24,624 Bottles (2025)

Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution nationwide after out-of-spec impurity D was detected. The product is distributed by Taro Pharmaceuticals in the United States and labeled Rx-only. Consumers must stop using the product and consult a healthcare provider for guidance.

Fluocinolone Acetonide
Failed Impurities/Degradation
Read more