Drug FDA Class II Ongoing Failed specifications
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
SUN PHARMA /TARO Published Dec 24, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact SUN PHARMA /TARO or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Hazards
Failed Impurity/Degradation Specifications · primary
Affected products (1)
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
17,664 units
Code info: Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Affected areas
Nationwide
Timeline
- InitiatedDec 9, 2025
- PublishedDec 24, 2025
- Recall number
- D-0240-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.