December 2025 FDA Recall Drug by Sun Pharma /taro
D-0240-2026 - Failed Impurity/Degradation specifications
This Class II drug recall was voluntarily initiated by Sun Pharma /taro on December 9, 2025 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0240-2026
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
12-09-2025
12-24-2025
17,664 units
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMA /TARO
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
