Quick answers
- What is Gadobutrol used for?
- The FDA-approved label (Gadavist, Bayer HealthCare Pharmaceuticals Inc., May 1, 2026) says: “GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gadobutrol have a boxed warning?
- Yes. The FDA label for Gadavist has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Gadobutrol?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 30, 2026). Ask your pharmacist about alternatives.
- Has Gadobutrol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gadobutrol?
- 6 companies list prescription products of Gadobutrol in the FDA NDC Directory, including Slate Run Pharmaceuticals, LLC, Viwit Pharmaceutical Co., Ltd. and Zydus Pharmaceuticals USA Inc..
What Gadobutrol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected …
— FDA label: Gadavist, Bayer HealthCare Pharmaceuticals Inc., effective May 1, 2026. Read the full label on DailyMed →
The FDA has 8 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.
This label has a boxed warning. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Slate Run Pharmaceuticals, LLC8 products
- Viwit Pharmaceutical Co., Ltd.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Bayer HealthCare Pharmaceuticals Inc.3 products
- Fresenius Kabi USA, LLC3 products
- GE Healthcare Inc.1 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 |
|---|---|---|---|
| NDA201277 GADAVIST | Bayer Hlthcare | March 14, 2011 | 21, latest July 28, 2026 2026: Labeling · 2026: Labeling · 2025: Labeling |
Generic approvals (5)
- ANDA215061Hengrui Pharma · November 17, 2022
- ANDA217480Hainan Poly Pharm · March 15, 2023
- ANDA216081Hengrui Pharma · September 8, 2023
- ANDA219287Viwit Pharm · June 11, 2026
- ANDA215957Ge Hlthcare · June 29, 2026
Shortage status
To be discontinued · updated June 30, 2026 · first posted June 30, 2026
| Product | Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15) |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | bd28560f-de4d-4140-874e-31df823f4dbb |
|---|---|
| FDA labels (SPL) | 8 |
| FDA applications | NDA201277, 5 ANDA |
| Active ingredients (FDA) | GADOBUTROL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gadavist, Bayer HealthCare Pharmaceuticals Inc., effective May 1, 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 →