Gadobutrol Injection
Brand names: Gadobutrol
Category: Medical Imaging
FDA status: To Be Discontinued · Last FDA update: Jun 30, 2026 · First posted: Jun 30, 2026 · 1 manufacturers, 4 listed presentations
As of Jun 30, 2026, the FDA lists Gadobutrol Injection as being discontinued. Of 4 manufacturer presentations, 4 Not specified.
| Presentation & package NDC | Manufacturer | Availability | FDA note |
|---|---|---|---|
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-10) NDC 65219-281-10 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Not specified | Discontinuance of single dose vials, the other two Imaging Bulk Package(IBP) strengths are to remain in supply: the IBP strengths (18.1416 g/30 mL and 39.3068 g/65 mL); Marketed by Fresenius Kabi, USA |
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02) NDC 65219-281-02 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Not specified | Discontinuance of single dose vials, the other two Imaging Bulk Package(IBP) strengths are to remain in supply: the IBP strengths (18.1416 g/30 mL and 39.3068 g/65 mL); Marketed by Fresenius Kabi, USA |
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15) NDC 65219-281-15 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Not specified | Discontinuance of single dose vials, the other two Imaging Bulk Package(IBP) strengths are to remain in supply: the IBP strengths (18.1416 g/30 mL and 39.3068 g/65 mL); Marketed by Fresenius Kabi, USA |
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-07) NDC 65219-281-07 |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Not specified | Discontinuance of single dose vials, the other two Imaging Bulk Package(IBP) strengths are to remain in supply: the IBP strengths (18.1416 g/30 mL and 39.3068 g/65 mL); Marketed by Fresenius Kabi, USA |
Related medications in shortage
Other Medical Imaging medications currently on the FDA shortage list — useful context if you and your prescriber are weighing alternatives. Always confirm with your pharmacist.
Change log
Tracking began Oct 1, 2026. We check the FDA every 6 hours; any real change - a manufacturer moving from Limited to Available, a new recovery date, a new listing - shows up here with its date.
Cite this: “FDA drug-shortage status for Gadobutrol Injection (FDA data as of Jun 30, 2026). Shortage Watch, openFDA.”
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FDA data last synced Oct 1, 2026 (FDA record dated Sep 30, 2026).