CLASS II ONGOING Drug recall · Reported 24 Dec 2025 · FDA Enforcement Report
Ciclopirox Shampoo recalled by Sun Pharma /taro
Sun Pharma /taro is recalling Ciclopirox Shampoo, 1%, distributed nationwide in the US. The recall was initiated on 9 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0240-2026
- FDA event ID
- 98104
- Recalling firm
- Sun Pharma /taro, Hawthorne, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Dec 2025
- FDA classified
- 17 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 9 Dec 2025 | Recall initiated by company | |
| 17 Dec 2025 | Classified by FDA | +8 days |
| 24 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Ciclopirox Shampoo, 1% recalled?
Yes. Sun Pharma /taro recalled Ciclopirox Shampoo, 1% on 9 Dec 2025. The recall is Class II and its status is Ongoing. Recall number D-0240-2026.
Why was it recalled?
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Which lots are affected?
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.