Quick answers
- What is Clevipidine used for?
- The FDA-approved label (Cleviprex, Chiesi USA, Inc., November 6, 2025) says: “Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clevipidine have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clevipidine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clevipidine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clevipidine?
- 2 companies list prescription products of Clevipidine in the FDA NDC Directory, including Chiesi USA, Inc. and Fresenius Kabi Austria GmbH.
What Clevipidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
— FDA label: Cleviprex, Chiesi USA, Inc., effective November 6, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Emulsion |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Cleviprex |
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.
- Chiesi USA, Inc.2 products
- Fresenius Kabi Austria GmbH1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022156 CLEVIPREX | Chiesi | August 1, 2008 | 4, latest April 16, 2021 2021: Labeling · 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 6, 2026 · Class II · Ongoing · D-0689-2026
Lack of Assurance of Sterility
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10. — Chiesi USA, Inc.
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).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cleviprex, Chiesi USA, Inc., effective November 6, 2025; 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 →