Recalls / Class II

Class IID-0240-2026

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

Affected lot / code info

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

Why it was recalled

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

Recalling firm

Firm

SUN PHARMA /TARO

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3 Skyline Dr, Hawthorne, New York 10532-2174

Distribution

Quantity

17,664 units

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2025-12-09

FDA classified

2025-12-17

Posted by FDA

2025-12-24

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0240-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.