Desonide Ointment — Class II drug recall D-0612-2017
Terminated recall by Fougera Pharmaceuticals Inc., reported 2017-03-29, distributed nationwide. Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment la
| Recall number | D-0612-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals Inc., Melville, NY, United States |
| Recall initiated | 2017-03-02 |
| Classified | 2017-03-23 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 14,665 tubes |
| Reason classes | labeling |
| NDC | 00168-0309-60 |
| Lot numbers | GC9231, GC9232 |
| Expiration dates | 2019-05 |
Product
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Reason for recall
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
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-0612-2017. 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.