LEO Pharma Inc.
NDC labeler code: 50222
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- SpesolimabSpevigo · 3 products
- Tralokinumab-ldrmAdbry · 2 products
- Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene monohydrate)Enstilar · 1 product
- DelgocitinibAnzupgo · 1 product
- Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene hydrate)Taclonex · 1 product
- Azelaic acidFinacea Foam, Azelex · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 23, 2025 | NDA219155 | Delgocitinib ANZUPGO | Leo Pharma As |
| September 1, 2022 | BLA761244 | Spesolimab SPEVIGO | Boehringer Ingelheim Pharmaceuticals Inc |
| December 27, 2021 | BLA761180 | Tralokinumab-ldrm ADBRY | Leo Pharma As |
| October 16, 2015 | NDA207589 | Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene monohydrate) ENSTILAR | Leo Pharma As |
| July 29, 2015 | NDA207071 | Azelaic acid FINACEA | Leo Pharma As |
| May 9, 2008 | NDA022185 | Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene hydrate) TACLONEX | Leo Pharma As |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
February 10, 2026 · Class II · Ongoing · D-0339-2026 · Tralokinumab-ldrm
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Phar
2017
-
January 16, 2017 · Class III · Terminated · D-0477-2017 · Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene hydrate)
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026