CLASS II Drug recall · Reported 29 Mar 2017 · FDA Enforcement Report
Desonide Ointment recalled by Fougera Pharmaceuticals
Fougera Pharmaceuticals is recalling Desonide Ointment, 05%, distributed nationwide in the US. The recall was initiated on 2 Mar 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0612-2017
- FDA event ID
- 76611
- Recalling firm
- Fougera Pharmaceuticals, Melville, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2017
- FDA classified
- 23 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Mar 2017 | Recall initiated by company | |
| 23 Mar 2017 | Classified by FDA | +21 days |
| 29 Mar 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Desonide Ointment, 05% recalled?
Yes. Fougera Pharmaceuticals recalled Desonide Ointment, 05% on 2 Mar 2017. The recall is Class II and its status is Terminated. Recall number D-0612-2017.
Why was it recalled?
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Which lots are affected?
Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fougera Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluocinonide Gel recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Fougera PharmaceuticalsTriamcinolone Acetonide | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Ketoconazole Cream, 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
Other Desonide recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desonide Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |