Ketoconazole recalls
Ketoconazole products have been recalled 3 times, most recently on 15 Jun 2022. The recalling company is usually Fougera Pharmaceuticals. The most common reason is potency & assay.
Total recalls3since 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 1 33%Class III 2 67%
Why ketoconazole is recalled
Companies
Product types
By year
All ketoconazole recalls, newest first
3 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 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 |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.