Akorn Desoximetasone Gel 0.05% Recall: Unknown Impurity Risk
Akorn recalls Desoximetas: 0.05% gel in 60g tubes (Rx only) due to failed impurity testing at 9 months. No remedy specified in official notice.
Recall notice
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Contact the company
What happened, in plain English
Akorn is recalling Desoximetasone Gel 0.05% in 60g aluminum tubes (Rx only) because it failed impurity testing at the 9-month stability point. This could mean the product contains harmful substances that might cause health issues if used. Read more at govinfonow.com/recall/42516-akorn-desoximetasone-gel-0-05-recall-unknown-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42516-akorn-desoximetasone-gel-0-05-recall-unknown-impurity-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-1469-2016
Cite this page
“Akorn Desoximetasone Gel 0.05% Recall: Unknown Impurity Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42516-akorn-desoximetasone-gel-0-05-recall-unknown-impurity-risk. Based on FDA recall #D-1469-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1469-2016%22&limit=1).
Why it’s dangerous
The gel failed impurity testing at the 9-month stability point, meaning it may contain harmful substances not detected in standard quality checks. This could lead to health issues if the product is used as intended.
Who’s affected
People with prescriptions for this gel are affected. Those using it for skin conditions may be at risk if the impurity causes adverse reactions.
How to tell if you have this one
Check for 60g aluminum tubes labeled 'Desoximetasone Gel USP 0.05%' with the NDC 61748-205-60. The product is prescription-only and sold by VersaPharm in the US.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, size, and NDC number on the tube to confirm it matches the recalled items.
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 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1469-2016 (July 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1469-2016 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.