Quick answers
- What is Dopamine hydrochloride used for?
- The FDA-approved label (DOPamine Hydrochloride, Hospira, Inc., May 13, 2026) says: “Dopamine HCl Injection is indicated to improve hemodynamic status in patients in distributive shock or shock due to reduced cardiac output. Dopamine HCl Injection is a catecholamine indicated to improve hemodynamic status in patients in shock.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dopamine hydrochloride have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dopamine hydrochloride?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Dopamine hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started September 4, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dopamine hydrochloride?
- 8 companies list prescription products of Dopamine hydrochloride in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Hospira, Inc. and Hikma Pharmaceuticals USA Inc..
What Dopamine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dopamine HCl Injection is indicated to improve hemodynamic status in patients in distributive shock or shock due to reduced cardiac output. Dopamine HCl Injection is a catecholamine indicated to improve hemodynamic status in patients in shock.
— FDA label: DOPamine Hydrochloride, Hospira, Inc., effective May 13, 2026. Read the full label on DailyMed →
The FDA has 14 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 14 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 | 25 in the FDA NDC Directory |
| Brand names | Dopamine Hydrochloride and 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
- Hikma Pharmaceuticals USA Inc.4 products
- Baxter Healthcare Corporation3 products
- ProPharma Distribution3 products
- Medical Purchasing Solutions, LLC2 products
- Henry Schein, Inc.2 products
- HF Acquisition Co. LLC, DBA Health First1 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 |
|---|---|---|---|
| NDA018132 DOPAMINE HYDROCHLORIDE | Hospira | May 19, 1981 | 27, latest September 12, 2023 2023: Labeling · 2014: Labeling · 2008: Labeling |
| NDA018826 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | Hospira | September 30, 1983 | 30, latest June 4, 2025 2025: Labeling · 2021: Labeling · 2014: Labeling |
| NDA019615 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | Baxter Hlthcare | March 27, 1987 | 20, latest December 11, 2020 2020: Labeling · 2017: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (1)
- ANDA207707Hikma Intl Pharms · April 11, 2018
Shortage status
Current shortage · updated October 21, 2026 · first posted November 6, 2017
| Product | Dopamine Hydrochloride, Injection, 200 mg/5mL (40 mg/1 mL) (NDC 0409-5820-01) |
|---|---|
| Availability | Available |
| Company | Hospira, Inc., a Pfizer Company |
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.
-
September 4, 2026 · Class II · Ongoing · D-0853-2026
Lack of Assurance of Sterility
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01. — Pfizer
-
September 29, 2014 · Class II · Terminated · D-0004-2015
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02. — Baxter Healthcare Corp.
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) — DOPamine Hydrochloride, Hospira, Inc., effective May 13, 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 →