Fougera Desonide Ointment 0.05% Label Mixup Recall
Fougera Pharmaceuticals recalls Desonide Ointment 0.05% tubes due to label mixup. Some units may contain Ketoconazole Cream instead of Desonide Ointment.
Lower-risk recall
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Contact the company
What happened, in plain English
Fougera Pharmaceuticals is recalling Desonide Ointment 0.05% tubes because some units may have the wrong label. This mix-up could lead to using the wrong medication, which might cause health issues. Read more at govinfonow.com/recall/41860-fougera-desonide-ointment-0-05-label-mixup-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/41860-fougera-desonide-ointment-0-05-label-mixup-recall · Updated October 8, 2026 · FDA enforcement record: FDA #D-0612-2017
Cite this page
“Fougera Desonide Ointment 0.05% Label Mixup Recall.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41860-fougera-desonide-ointment-0-05-label-mixup-recall. Based on FDA recall #D-0612-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0612-2017%22&limit=1).
Why it’s dangerous
The label mix-up means some unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment that are actually labeled as Ketoconazole Cream. Using the wrong medication could cause health problems.
Who’s affected
Prescription users of Desonide Ointment 0.05% tubes from Fougera Pharmaceuticals. Those with the specific lot numbers (GC9231 or GC9232) are most at risk.
How to tell if you have this one
Check for the product name on the tube label: Desonide Ointment 0.05% or Ketoconazole Cream. Look for lot numbers GC9231 or GC9232 (expiring May 2019).
- Brand
Fougera Pharmaceuticals- Category
Drug
What to do — step by step
Check Label
Verify the tube label says Desonide Ointment 0.05% and not Ketoconazole Cream.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall is due to a label mix-up, not a safety issue. If the label is correct, the product is safe.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0612-2017 (March 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0612-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.