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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

Taro Ciclopirox Shampoo Recalled for Quality Specification Failure

Agency Publication Date: December 17, 2025
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Summary

Sun Pharma / Taro is recalling 17,664 units of Ciclopirox Shampoo (1%) because the product failed quality tests for impurity and degradation levels at the 18-month mark. This prescription-only medicated shampoo, used to treat fungal skin conditions, was distributed in 120 mL bottles nationwide. Consumers who have this product should check their lot numbers to see if their medication is part of the affected batches.

Risk

The shampoo failed to meet chemical stability standards over time, which may result in higher-than-allowed impurity levels or a loss of effectiveness. This degradation could lead to reduced treatment efficacy or potential irritation for the user.

What You Should Do

  1. Check the lot number printed on your shampoo bottle or carton. The affected lot numbers are AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, and AD37068, all with an expiration date of 1/31/2026.
  2. 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.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

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: Ciclopirox Shampoo (120 mL)
Variants: 1%, Rx only
Lot Numbers:
AD37059 (Exp 1/31/2026)
AD37060 (Exp 1/31/2026)
AD37061 (Exp 1/31/2026)
AD37062 (Exp 1/31/2026)
AD37065 (Exp 1/31/2026)
AD37066 (Exp 1/31/2026)
AD37067 (Exp 1/31/2026)
AD37068 (Exp 1/31/2026)
NDC:
51672-1351-08

Manufactured by Taro Pharmaceuticals Inc., Ontario, Canada; Distributed by Taro Pharmaceuticals USA, Inc., NY 10532.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98104
Status: Active
Manufacturer: SUN PHARMA /TARO
Sold By: Retail pharmacies
Manufactured In: Canada, United States
Units Affected: 17,664 units
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.