HIGHFDA DRUG

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...

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

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
March 25, 2026
Status
ACTIVE

Quick Facts at a Glance

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
FLUOCINONIDE, Sun Pharmaceutical Industries, Inc.
Model numbers
Lot# AD76252, Exp Date: 6/30/2026.
UPC codes
51672-1386, 51672-1386-1, 51672-1386-2, 51672-1386-3, 51672-1386-4
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 25, 2026

  2. Reported by FDA DRUG

    April 22, 2026

  3. RecallRadar source check

    April 29, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

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Full Description

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. 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: 24,672 15 g 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

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Product Classification

Product Details

Model Numbers
Lot# AD76252
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

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