SUN PHARMA Ciclopirox Shampoo 1% Recall: Failed Impurity Test at 18 Months
SUN PHARMA recalls Ciclopirox Shampoo 1% (120mL) due to impurity issues detected at 18 months. Rx only product with specific lots and expiration date. No remedy stated in official notice.
Recall notice
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Contact the company
What happened, in plain English
SUN PHARMA has recalled Ciclopirox Shampoo 1% (120 mL) that was found to have impurity issues at the 18-month mark. This product is prescription-only and was manufactured by Taro Pharmaceuticals in Ontario, Canada. The recall affects specific lots with an expiration date of January 31, 2026. Read more at govinfonow.com/recall/31621-sun-pharma-ciclopirox-shampoo-1-recall-failed-impurity-test-at.
Source Summary by GovInfoNow · govinfonow.com/recall/31621-sun-pharma-ciclopirox-shampoo-1-recall-failed-impurity-test-at · Updated August 17, 2026 · FDA enforcement record: FDA #D-0240-2026
Cite this page
“SUN PHARMA Ciclopirox Shampoo 1% Recall: Failed Impurity Test at 18 Months.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31621-sun-pharma-ciclopirox-shampoo-1-recall-failed-impurity-test-at. Based on FDA recall #D-0240-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0240-2026%22&limit=1).
Why it’s dangerous
The product failed impurity and degradation tests at the 18-month timepoint, indicating potential harmful substances may have developed. This could pose health risks if the impurities are not properly controlled in the product.
Who’s affected
Prescription users of Ciclopirox Shampoo 1% (120 mL) with specific lot numbers from Taro Pharmaceuticals in Ontario, Canada. Most at risk are those who have used the product within the 18-month timeframe.
How to tell if you have this one
Check for the product name 'Ciclopirox Shampoo 1%', 120 mL size, and prescription label. Look for lot numbers AD37059 through AD37068 with expiration date January 31, 2026.
- Brand
SUN PHARMA /TARO- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, size, and lot numbers to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0240-2026 (December 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0240-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.