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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Fluocinonide 0.05% Cream Recalled for Higher Than Specified Viscosity

Agency Publication Date: April 13, 2026
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Summary

SUN PHARMACEUTICAL INDUSTRIES INC is recalling 69,024 tubes of Fluocinonide (USP, 0.05%) cream due to testing showing the product's thickness (viscosity) is higher than required specifications. The recall affects 15g, 30g, and 60g tubes manufactured by Taro Pharmaceuticals. This defect was discovered during stability testing and may affect how the cream is dispensed or applied. No injuries or incidents have been reported in connection with this issue.

Risk

The cream's viscosity is above the specification limit, which may alter the physical consistency of the medication and potentially impact the patient's experience during application. While no health incidents are reported, the medication does not meet the manufacturer's quality standards for its formulated consistency.

What You Should Do

  1. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  2. Check your medication tubes for the following Lot Numbers and National Drug Codes (NDC): for 15g tubes, look for Lot# AD76252 (NDC 51672-1386-1); for 30g tubes, look for Lot# AD76251 (NDC 51672-1386-2); and for 60g tubes, look for Lot# AD76250 (NDC 51672-1386-3). All affected lots have an expiration date of 6/30/2026.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fluocinonide, USP, 0.05% Cream (15g tube)
Variants: Rx only, Cream
Lot Numbers:
AD76252 (Exp 6/30/2026)
NDC:
51672-1386-1

Manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada; Distributed by Taro Pharmaceuticals U.S.A., Inc.

Product: Fluocinonide, USP, 0.05% Cream (30g tube)
Variants: Rx only, Cream
Lot Numbers:
AD76251 (Exp 6/30/2026)
NDC:
51672-1386-2

Manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada; Distributed by Taro Pharmaceuticals U.S.A., Inc.

Product: Fluocinonide, USP, 0.05% Cream (60g tube)
Variants: Rx only, Cream
Lot Numbers:
AD76250 (Exp 6/30/2026)
NDC:
51672-1386-3

Manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada; Distributed by Taro Pharmaceuticals U.S.A., Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98677
Status: Active
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: Canada, United States
Units Affected: 69,024
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.