Fougera Ketoconazole Cream 2% — Class III drug recall D-241-2013
Terminated recall by Fougera Pharmaceuticals Inc., reported 2013-04-10, distributed nationwide. Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall
| Recall number | D-241-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals Inc., Melville, NY, United States |
| Recall initiated | 2012-07-18 |
| Classified | 2013-04-02 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2015-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 60,210 units |
| Reason classes | specification failure |
| NDC | 00168-0099, 00168-0099-15, 00168-0099-30, 00168-0099-60 |
| Lot numbers | 07/12, 835H |
Product
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
Reason for recall
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-241-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.