FDA Drug recall D-0612-2017
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 1…
- FDA Drug
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 1… by Fougera Pharmaceuticals, citing labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0612-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-02 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
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
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Identifiers
| code_info | Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Fougera Pharmaceuticals
- FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes,…
FDA Drug · Class II · 2014-11-19 · Fougera Pharmaceuticals - Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Divi…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals - Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Di…
FDA Drug · Class III · 2014-07-23 · Fougera Pharmaceuticals - Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., M…
FDA Drug · Class III · 2014-03-19 · Fougera Pharmaceuticals - KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC…
FDA Drug · Class III · 2014-02-05 · Fougera Pharmaceuticals
All Fougera Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0612-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.