Warning
SUN PHARMA /TARO Recalls Ciclopirox Shampoo
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0240-2026Drug / Pharmaceutical
SUN PHARMA /TARO Recalls Ciclopirox Shampoo
SUN PHARMA /TARO · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
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.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
SUN PHARMA /TARO has recalled a pharmaceutical product that the FDA classified as Class II affecting 17,664 units. The recall was initiated on December 9, 2025. Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.