Taro recalls Ciclopirox 1% shampoo over failed impurity and breakdown tests
Testing at the 18-month point found the shampoo had results outside the allowed limits for impurities and product breakdown, so it did not meet quality standards.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall details
- Product
- Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
- Company
- Sun Pharma /Taro
- Hazard
- Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- Units
- 17,664 units
- Where sold
- Nationwide within the United States
- FDA classification
- Class II · Ongoing
- Classified by FDA
- December 17, 2025
- Recall started
- December 9, 2025
- FDA enforcement report
- December 24, 2025
- Identifiers
- Codes: Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
- FDA recall number: D-0240-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
- Reason for recall
- Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 17,664 units
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