LEO Pharma Calcipotriene Cream 0.0005% Recall: Incorrect Labeling Risk
LEO Pharma recalls Calcipotriene Cream 0.0005% tubes due to missing drug excipient warnings and contact dermatitis risks in labeling. Affected products include 60g and 120g tubes with specific NDC numbers.
Lower-risk recall
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Contact the company
What happened, in plain English
LEO Pharma is recalling Calcipotriene Cream 0.0005% tubes because the labeling missed critical warnings about contact dermatitis and omitted a drug excipient. This could lead to skin irritation or allergic reactions if users don't see the proper safety information. Read more at govinfonow.com/recall/42074-leo-pharma-calcipotriene-cream-0-0005-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42074-leo-pharma-calcipotriene-cream-0-0005-recall-incorrect-labeling-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0510-2017
Cite this page
“LEO Pharma Calcipotriene Cream 0.0005% Recall: Incorrect Labeling Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42074-leo-pharma-calcipotriene-cream-0-0005-recall-incorrect-labeling-risk. Based on FDA recall #D-0510-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0510-2017%22&limit=1).
Why it’s dangerous
The recall involves missing warnings about contact dermatitis and an omitted drug excipient in the labeling. This means users might not be aware of potential skin irritation or allergic reactions, especially if they have sensitive skin.
Who’s affected
Prescription users of Calcipotriene Cream 0.0005% are affected, particularly those with sensitive skin who may experience contact dermatitis. Patients using the product without proper labeling guidance are at higher risk.
How to tell if you have this one
Check for 60g or 120g tubes with NDC numbers 66993-877-61 or 66993-877-78. The product is prescription-only and manufactured by LEO Pharma Inc.
- Brand
LEO Pharma- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC numbers 66993-877-61 (60g tube) or 66993-877-78 (120g tube) on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. 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 II
- 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-0510-2017 (January 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0510-2017 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.