Ciclopirox Shampoo recall
FDA recall D-0240-2026 · initiated Dec 9, 2025
SUN PHARMA /TARO recalled Ciclopirox Shampoo in Dec 2025 — an FDA Class II recall (D-0240-2026) because Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 17,664 units
Details
- 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
- Recalling company
- SUN PHARMA /TARO
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Dec 9, 2025
- FDA report date
- Dec 24, 2025
Frequently asked
- Was Ciclopirox Shampoo recalled?
- SUN PHARMA /TARO recalled Ciclopirox Shampoo in Dec 2025 — an FDA Class II recall (D-0240-2026) because Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ciclopirox Shampoo recalled?
- Per the FDA enforcement record, the reason for recall D-0240-2026 was: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- Is a recalled Ciclopirox Shampoo dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ciclopirox Shampoo are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0240-2026.