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Gadobutrol Injection

Brand names: Gadobutrol

Category: Medical Imaging

Not specified 4

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.

Ask your pharmacist: which of the 1 manufacturers below can they order right now, and whether a different strength or form of Gadobutrol Injection is available. For alternatives, talk to your prescriber — see what to do if your medication is in shortage.
Presentation & package NDCManufacturerAvailabilityFDA 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

No changes recorded yet.
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).