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Gadobutrol Injection shortage

To Be Discontinued  4 presentations · 1 manufacturers · first FDA posting Jun 30, 2026 · last update Jun 30, 2026

Manufacturers: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Stated reasons (per FDA): Not stated

More info: FDA Drug Shortages Database · ASHP drug shortages list (search there for this drug)

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02)Jiangsu Hengrui Pharmaceuticals Co., Ltd.To Be Discontinued
—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, USAPosted Jun 30, 2026
Updated Jun 30, 2026
Discontinued Jun 30, 2026
Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-07)Jiangsu Hengrui Pharmaceuticals Co., Ltd.To Be Discontinued
—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, USAPosted Jun 30, 2026
Updated Jun 30, 2026
Discontinued Jun 30, 2026
Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-10)Jiangsu Hengrui Pharmaceuticals Co., Ltd.To Be Discontinued
—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, USAPosted Jun 30, 2026
Updated Jun 30, 2026
Discontinued Jun 30, 2026
Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15)Jiangsu Hengrui Pharmaceuticals Co., Ltd.To Be Discontinued
—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, USAPosted Jun 30, 2026
Updated Jun 30, 2026
Discontinued Jun 30, 2026

Source: FDA Drug Shortages Database · raw openFDA records

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