Quick answers
- Is there a shortage of Terlipressin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Terlipressin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 6, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Terlipressin?
- 1 company lists prescription products of Terlipressin in the FDA NDC Directory, including Keenova Hospital Products Inc..
What Terlipressin is used for
We did not find an “Indications and Usage” section in the FDA labels for this medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Terlivaz |
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.
- Keenova Hospital Products 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 |
|---|---|---|---|
| NDA022231 TERLIVAZ | Mallinckrodt Ireland | September 14, 2022 | 2, latest June 10, 2026 2026: Labeling · 2023: Labeling |
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.
-
February 6, 2024 · Class II · Ongoing · D-0341-2024
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01 — Mallinckrodt Hospital Products 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
| FDA labels (SPL) | 0 |
|---|---|
| FDA applications | NDA022231 |
| Active ingredients (FDA) | TERLIPRESSIN |
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
- 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 →