KETOCONAZOLE CREAM — Class III drug recall D-1044-2014
Terminated recall by Fougera Pharmaceuticals Inc., reported 2014-02-05, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
| Recall number | D-1044-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals Inc., Melville, NY, United States |
| Recall initiated | 2013-11-18 |
| Classified | 2014-01-30 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2016-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 31,122 tubes |
| Reason classes | specification failure |
| NDC | 00168-0099, 00168-0099-15, 00168-0099-30, 00168-0099-60 |
| Lot numbers | 07/14, 495P |
Product
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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-1044-2014. 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.