Quick answers
- What is Levoketoconazole used for?
- The FDA-approved label (Recorlev, Xeris Pharmaceuticals, Inc., March 10, 2026) says: “RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levoketoconazole have a boxed warning?
- Yes. The FDA label for Recorlev has a boxed warning (“WARNING: HEPATOTOXICITY AND QT PROLONGATION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Levoketoconazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levoketoconazole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Levoketoconazole?
- 1 company lists prescription products of Levoketoconazole in the FDA NDC Directory, including Xeris Pharmaceuticals, Inc..
What Levoketoconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established. …
— FDA label: Recorlev, Xeris Pharmaceuticals, Inc., effective March 10, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: HEPATOTOXICITY AND QT PROLONGATION
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Recorlev |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Xeris Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA214133 RECORLEV | Strongbridge | December 30, 2021 | 1, latest August 16, 2023 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2588848, 2588854 |
|---|---|
| SPL set ID of the quoted label | d4c5fead-bc4a-fb02-e053-2a95a90ae4fc |
| FDA labels (SPL) | 1 |
| FDA applications | NDA214133 |
| Active ingredients (FDA) | LEVOKETOCONAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Recorlev, Xeris Pharmaceuticals, Inc., effective March 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →