Quick answers
- What is Milrinone lactate used for?
- The FDA-approved label (Milrinone Lactate in Dextrose, Hikma Pharmaceuticals USA Inc., May 18, 2026) says: “Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Milrinone lactate have a boxed warning?
- No. None of the 19 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Milrinone lactate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Milrinone lactate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started August 14, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Milrinone lactate?
- 13 companies list prescription products of Milrinone lactate in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Caplin Steriles Limited and Somerset Therapeutics, LLC.
What Milrinone lactate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. …
— FDA label: Milrinone Lactate in Dextrose, Hikma Pharmaceuticals USA Inc., effective May 18, 2026. Read the full label on DailyMed →
The FDA has 19 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 39 in the FDA NDC Directory |
| Brand names | Milrinone Lactate in Dextrose |
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.
- Hikma Pharmaceuticals USA Inc.8 products
- Caplin Steriles Limited5 products
- Somerset Therapeutics, LLC5 products
- Mullan Pharmaceutical Inc.3 products
- Armas Pharmaceuticals Inc.3 products
- Shandong New Time Pharmaceutical Co., Ltd.3 products
- Hospira, Inc.3 products
- Baxter Healthcare Corporation2 products
- Eugia US LLC2 products
- Gland Pharma Limited2 products
- Fresenius Kabi USA, LLC1 product
- Sagent Pharmaceuticals1 product
- Meitheal Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (11)
- ANDA075834Baxter Hlthcare · May 28, 2002
- ANDA075936Fresenius Kabi USA · May 28, 2002
- ANDA090038Hikma Farmaceutica · January 21, 2010
- ANDA077966Hikma Farmaceutica · December 3, 2010
- ANDA203280Hospira · September 3, 2014
- ANDA211671Meitheal · March 24, 2020
- ANDA213585Gland · July 16, 2020
- ANDA209666Eugia Pharma · September 3, 2020
- ANDA214380Caplin · April 16, 2021
- ANDA216373Shandong · January 23, 2023
- ANDA219170Caplin · September 2, 2025
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.
-
August 14, 2023 · Class III · Terminated · D-1144-2023
Failed Impurities/Degradation Specifications
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: — Caplin Steriles Limited
-
May 15, 2017 · Class II · Terminated · D-0789-2017
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48 — Baxter Healthcare Corporation
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) — Milrinone Lactate in Dextrose, Hikma Pharmaceuticals USA Inc., effective May 18, 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 →