Gadobutrol Injection shortage
To Be Discontinued 4 presentations · 1 manufacturers · first FDA posting 2026-06-30 · last update 2026-06-30
Manufacturers: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Stated reasons (per FDA): Not stated
Presentations
| Presentation | Manufacturer | Status | Reason | Notes (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, USA | Posted 06/30/2026 Updated 06/30/2026 Discontinued 06/30/2026 |
| 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, USA | Posted 06/30/2026 Updated 06/30/2026 Discontinued 06/30/2026 |
| 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, USA | Posted 06/30/2026 Updated 06/30/2026 Discontinued 06/30/2026 |
| 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, USA | Posted 06/30/2026 Updated 06/30/2026 Discontinued 06/30/2026 |
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