D-0240-2026 Class II Ongoing

Recalled by SUN PHARMA /TARO — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
December 24, 2025
Initiation Date
December 9, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,664 units

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.