LEO Pharma Taclonex Topical Suspension Recall: Out-of-date Package Insert
LEO Pharma recalls Taclonex topical suspension with outdated package insert (dated Feb 2014) to ensure proper usage instructions.
Lower-risk recall
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Contact the company
What happened, in plain English
LEO Pharma is recalling Taclonex topical suspension products that came with an outdated package insert from February 2014. This recall is needed to prevent potential misuse due to incorrect labeling. Read more at govinfonow.com/recall/42087-leo-pharma-taclonex-topical-suspension-recall-out-of-date-package.
Source Summary by GovInfoNow · govinfonow.com/recall/42087-leo-pharma-taclonex-topical-suspension-recall-out-of-date-package · Updated October 8, 2026 · FDA enforcement record: FDA #D-0477-2017
Cite this page
“LEO Pharma Taclonex Topical Suspension Recall: Out-of-date Package Insert.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42087-leo-pharma-taclonex-topical-suspension-recall-out-of-date-package. Based on FDA recall #D-0477-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0477-2017%22&limit=1).
Why it’s dangerous
The package insert (PI) was dated February 2014, but the product was manufactured later. This outdated PI may not contain current usage instructions, potentially leading to improper application. However, the hazard does not involve immediate physical harm like injury or illness.
Who’s affected
Prescription users of Taclonex topical suspension who received products with the outdated package insert. Patients using the product without proper instructions may be at risk of incorrect application.
How to tell if you have this one
Check for Taclonex topical suspension (0.005%/0.064%) in 60g or 120g tubes with lot numbers listed in the recall notice. The package insert should be dated February 2014 or later.
- Brand
LEO Pharma- Category
Drug
What to do — step by step
Check Package Insert Date
Look for the package insert (PI) dated February 2014 or earlier on the product's packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 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-0477-2017 (January 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0477-2017 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.