Gadobutrol Injection shortage
Gadobutrol Injection is currently listed in shortage by the FDA. The FDA lists 4 affected products. This page was last refreshed from FDA data on Oct 3, 2026.
Jiangsu Hengrui is stopping its gadobutrol injection single-dose vials, and that change may be permanent. The same strength — Gadavist (gadobutrol) 604.72 mg/mL — is still listed by other makers not reporting a shortage.
Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).
Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →What’s in shortage — at a glance
These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Gadobutrol Injection. Other makers that haven’t reported a problem are shown in the green card below.
Shortage timeline
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Jun 30, 2026Currently in shortage4 of 4 products affected.
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Jun 30, 2026First reported to the FDA4 products first listed.
Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.
What exactly is on backorder — by manufacturer
Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd. 📞 888-386-1300 4 NDCS click to expand
| Status | NDC / product | Strength | Availability | Related information | Reason |
|---|---|---|---|---|---|
| To Be Discontinued | Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-10) | — | — | 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 | — |
| To Be Discontinued | Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-07) | — | — | 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 | — |
| To Be Discontinued | Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15) | — | — | 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 | — |
| To Be Discontinued | Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02) | — | — | 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 | — |
These rows are manufacturer reports to the FDA for Gadobutrol Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Gadobutrol Injection? options further down this page.
Why is Gadobutrol Injection in shortage?
Jiangsu Hengrui Pharmaceuticals (marketed in the U.S. by Fresenius Kabi) has permanently stopped making their single-dose vials of gadobutrol injection 604.72 mg/mL. The FDA report doesn't include a specific reason for why this decision was made — the manufacturer simply did not share one publicly.
The good news is that this is not a full discontinuation of the product from this manufacturer. Their two larger Imaging Bulk Package sizes — the 18.1416 g/30 mL and the 39.3068 g/65 mL packages — are expected to remain available. So it's specifically the individual, single-dose vial format that is going away, not every version of this product from this company.
Based on the manufacturer-reported reason(s) and notes on file with the FDA for Gadobutrol Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.
What should I do if I take Gadobutrol Injection?
Gadobutrol injection (604.72 mg/mL) is currently on the FDA shortage list. This is a contrast dye used during certain MRI scans, so it is usually given at an imaging center or hospital rather than taken at home.
The affected product is the single-dose vial of the 604.72 mg/mL strength, which has no available source reported right now. The manufacturer has marked this item as to be discontinued, which means this particular supply problem may be permanent. Two larger Imaging Bulk Package sizes (18.1416 g/30 mL and 39.3068 g/65 mL) are reported to remain in supply. Because this record reflects only one filing, other companies may still carry this medicine.
What you can do:
- Do not skip or delay your scan on your own — your imaging team manages the contrast supply.
- Let your imaging center know; they can check wholesalers and other makers for an available source.
- The same medicine (gadobutrol 604.72 mg/mL) is also listed from other suppliers, including Gadavist from Bayer, Fresenius Kabi, and Slate Run. Your facility may be able to source one of these, though it may not be in local stock.
- Manufacturer contact numbers are listed on this page for reference; facilities usually handle these calls.
This is national, manufacturer-reported data and may not match local stock. It is general information, not personal medical advice.
- Don’t stop or change the medication on your own — talk to your prescriber first.
- If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
- Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
- Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.
Where else can I get Gadobutrol Injection?
FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Gadobutrol Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.
Same medicine, other manufacturers (not reported short)
Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:
| Product | Strength | Form / route | Manufacturer | NDC |
|---|---|---|---|---|
| Gadavist | GADOBUTROL 604.72 mg/mL | Injection · Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-0325-11 |
| Gadobutrol | GADOBUTROL 604.72 mg/mL | Injection · Intravenous | Fresenius Kabi USA, LLC | 65219-0287-30 |
| Gadobutrol | GADOBUTROL 604.72 mg/mL | Injection · Intravenous | Slate Run Pharmaceuticals, LLC | 70436-0212-54 |
Therapeutic equivalents & pricing 18 productsclick to expand
Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.
| Product | Manufacturer | Package | NADAC $/unit | AB rating | Availability |
|---|---|---|---|---|---|
| Gadobutrol 604.72 mg/mL | Fresenius | 10 bottles | — | — | FDA listed |
| gadobutrol 604.72 mg/mL | Slate | 1 vial | — | AP | FDA listed |
| Gadavist 604.72 mg/mL | Bayer | 5 bottles | — | AP | Discontinued |
| gadobutrol 604.72 mg/mL | Slate | 20 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Slate | 10 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Slate | 3 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Slate | 20 vials | — | AP | FDA listed |
| Gadobutrol 604.72 mg/mL | Fresenius | 10 bottles | — | — | FDA listed |
| gadobutrol 604.72 mg/mL | Slate | 5 vials | — | AP | FDA listed |
| Gadobutrol 604.72 mg/mL | Fresenius | 10 vials | — | — | FDA listed |
| gadobutrol 604.72 mg/mL | Viwit | 10 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Zydus | 10 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Viwit | 10 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Zydus | 10 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Zydus | 10 vials | — | AP | FDA listed |
| gadobutrol 604.72 mg/mL | Viwit | 10 vials | — | AP | FDA listed |
| Gadobutrol 604.72 mg/mL | Fresenius | 10 vials | — | — | FDA listed |
| Gadobutrol 604.72 mg/mL | Fresenius | 10 vials | — | — | FDA listed |
Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.
Other drugs in the same treatment class
These are different medicines — not other versions of Gadobutrol Injection — that fall in the same broad treatment class (diagnostic preparations,miscellaneous) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.
Identity & classification
Where does this data come from?
Other medical imaging shortages
Gadobutrol Injection shortage FAQs
Is Gadobutrol Injection in shortage?
Which products are affected?
When will Gadobutrol Injection be available again?
Can I still get Gadobutrol somewhere?
What should I do if I take Gadobutrol Injection?
Still have a question about the Gadobutrol Injection shortage?
Ask a pharmacist about this shortage →View Gadobutrol Injection on the FDA drug-shortage database →
Where does this data come from?
/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.