Sandoz Ketoconazole Shampoo Recall: Subpotent Drug Risk
Sandoz recalls 391,055 bottles of Ketoconazole Shampoo 2% manufactured by Tolmar due to subpotency issues. Check your lot numbers for details.
Use caution until it’s fixed
Subpotent
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What happened, in plain English
Tolmar, Inc., manufacturing for Sandoz Inc., is recalling specific lots of Ketoconazole Shampoo 2% because the product may be subpotent. This means the medication might not contain enough active ingredient to work as intended. The recall covers approximately 391,055 bottles distributed nationwide. Read more at govinfonow.com/recall/46585-tolmar-inc-recalls-ketoconazole-shampoo-2-manufactured-by-tolmar-inc.
Source Summary by GovInfoNow · govinfonow.com/recall/46585-tolmar-inc-recalls-ketoconazole-shampoo-2-manufactured-by-tolmar-inc · Updated October 13, 2026 · FDA enforcement record: FDA #D-66402-001
Cite this page
“Sandoz Ketoconazole Shampoo Recall: Subpotent Drug Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46585-tolmar-inc-recalls-ketoconazole-shampoo-2-manufactured-by-tolmar-inc. Based on FDA recall #D-66402-001 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66402-001%22&limit=1).
Why it’s dangerous
The shampoo is classified as subpotent, meaning it may not deliver the full dose of ketoconazole required to treat infections effectively. Using a subpotent antifungal can lead to persistent or worsening skin conditions because the medication fails to kill the fungus adequately.
Who’s affected
Consumers who purchased Ketoconazole Shampoo 2% between late 2013 and mid-2014 from various locations nationwide. Individuals relying on this medication for fungal skin conditions are most at risk of ineffective treatment.
How to tell if you have this one
Check your bottle for NDC 0781-7090-04 and look at the expiration date on the label. Affected lots include those expiring in 2013 (e.g., 5307A, 5391A) and 2014 (e.g., 6111A, 6191A). The manufacturer is Tolmar, Inc., Fort Collins, CO.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your shampoo has NDC 0781-7090-04 and an expiration date between October 2013 and October 2014.
Discontinue Use
Stop using the recalled shampoo immediately if it matches the affected lot numbers to avoid ineffective treatment.
Contact Manufacturer
Reach out to Tolmar, Inc. or Sandoz Inc. for further instructions on disposal or replacement, as specific remedy details are not provided in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are affected by this recall?
Affected lots include 6111A, 6191A, 5523A, 5617A, 5619A, 5660A, 5689A, 5690A, 6114A, 6115A, 6118A, 6122A, 5307A, 5391A, 5393A, 5392A, 5394A, 5396A, 5430A, 5431A, 5432A, 5434A, 5578A, 5491A, 5492A, 5493A, 5494A, 5531A, 5661A, 5490A, 5533A, 5495A, 5534A, 5535A, 5621A, 5728A, 6117A, 6113A, 5776A, 6112A, 6119A, 6192A, and 6123A.
Where was this product sold?
The product was distributed nationwide across the United States.
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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-66402-001 (September 23, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-66402-001 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.