Quick answers
- What is Dobutamine in dextrose used for?
- The FDA-approved label (Dobutamine Hydrochloride in Dextrose, Baxter Healthcare Corporation, September 8, 2023) says: “Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dobutamine in dextrose have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dobutamine in dextrose?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Dobutamine in dextrose been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 28, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dobutamine in dextrose?
- 5 companies list prescription products of Dobutamine in dextrose in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Hospira, Inc. and Baxter Healthcare Corporation.
What Dobutamine in dextrose is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. …
— FDA label: Dobutamine Hydrochloride in Dextrose, Baxter Healthcare Corporation, effective September 8, 2023. Read the full label on DailyMed →
The FDA has 10 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 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Dobutamine Hydrochloride 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.
- HF Acquisition Co LLC, DBA HealthFirst5 products
- Hospira, Inc.5 products
- Baxter Healthcare Corporation3 products
- Hikma Pharmaceuticals USA Inc.1 product
- Slate Run Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020201 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | Hospira | September 27, 1993 | 20, latest November 25, 2025 2025: Manufacturing (CMC) · 2024: Labeling · 2019: Labeling |
| NDA020255 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | Baxter Hlthcare | September 27, 1993 | 15, latest September 8, 2023 2023: Labeling · 2020: Labeling · 2019: Labeling |
Generic approvals (3)
- ANDA074086Hospira · November 29, 1993
- ANDA074277Hikma · October 31, 1994
- ANDA216131Hainan Poly · December 21, 2022
Shortage status
Current shortage · updated October 21, 2026 · first posted November 6, 2017
| Product | Dobutamine Hydrochloride, Injection, 250 mg/20 mL (NDC 70436-203-80) |
|---|---|
| Availability | Available |
| Company | Hainan Poly Pharm. Co., Ltd. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
May 28, 2025 · Class II · Ongoing · D-0489-2025
Discoloration; discolored solution from cracked vials
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC — Pfizer Inc.
-
January 10, 2014 · Class I · Terminated · D-1540-2014
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02 — Hospira Inc.
-
April 30, 2013 · Class II · Terminated · D-502-2013
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32 — Hospira 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
| RxCUI (RxNorm) | 309985, 309986, 309987, 1812168 |
|---|---|
| SPL set ID of the quoted label | 6b17b98b-e06d-42ed-925f-69aa2699dead |
| FDA labels (SPL) | 10 |
| FDA applications | NDA020201, NDA020255, 3 ANDA |
| Active ingredients (FDA) | DOBUTAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dobutamine Hydrochloride in Dextrose, Baxter Healthcare Corporation, effective September 8, 2023; 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 →