FDA recall D-0240-2026

SUN PHARMA /TARO · Class II · drug

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

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2025-12-09
Report date: 2025-12-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0240-2026