Ketoconazole recalls
The FDA has published 4 recalls involving Ketoconazole since 2013. The latest was reported on 15 Jun 2022. Most were for potency & assay. Fougera Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls4since 2013
Last 12 months0reported
Class I00% of total
Ongoing0latest 15 Jun 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 50%Class III 2 50%
Why ketoconazole is recalled
Companies
By year
All ketoconazole recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketoconazole Cream recalled by Mckesson Medical-SurgicalKetoconazole | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ketoconazole USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS III | Ketoconazole Cream, 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fougera Ketoconazole Cream 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
Should you stop taking Ketoconazole?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.