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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 17,664
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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