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CLASS II · ModerateFDA

SUN PHARMA /TARO recalls Ciclopirox Shampoo

📅 Dec 9, 2025 · 📍 Nationwide
Recalling company
SUN PHARMA /TARO
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
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 9, 2025
Reported
Dec 24, 2025
Distribution
Nationwide within the United States
Status
Ongoing
Quantity
17,664 units
Lot / codes
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Company location
Hawthorne, NY
Recall type
Voluntary: Firm initiated
Recall number
D-0240-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0240-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.