Ciclopirox shampoo recalled after failing impurity specifications at eighteen months
Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an out of specification impurity result with no stated clinical consequence or reported harm.
Plain-English summary
Ciclopirox Shampoo, 1%, 120 mL, manufactured by Taro Pharmaceuticals Inc. of Ontario, Canada and distributed by Taro Pharmaceuticals USA, Inc. of New York under NDC 51672-1351-08, is being recalled.
The reason given in the enforcement record is failed impurity and degradation specifications, with out of specification results obtained at the 18-month timepoint.
The recall covers 17,664 units from lots AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067 and AD37068, all expiring 1/31/2026. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
The record describes a specification failure rather than a reported patient harm. Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific lot is affected.
The recalled product
- 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
- Manufacturer
- SUN PHARMA /TARO
- Category
- Drug — Antifungal shampoo
- Hazard
- impurity
- out-of-specification
- stability-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: AD37059
- AD37060
- AD37061
- AD37062
- AD37065
- AD37066
- AD37067
- AD37068
- expires: 1/31/2026.
Distribution
Distributed nationwide across the United States.
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