Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist...
FDA Recall #D-0240-2026 — Class II — December 9, 2025
Product Description
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
Recalling Firm
SUN PHARMA /TARO — Hawthorne, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
17,664 units
Distribution
Nationwide within the United States
Code Information
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated