Is there an Omnipaque or contrast media shortage right now?
FDA does not list an Omnipaque shortage. A check of FDA's shortage data on Oct. 30, 2026 returned no record for Omnipaque, and none for iodixanol, iopamidol, ioversol, iopromide, gadoteridol, gadobenate, gadopiclenol or gadoxetate. It also returned no GE HealthCare or Guerbet records. FDA's shortage list page showed no entry for Omnipaque, iodixanol, iopamidol or ioversol. Absence from FDA's list does not prove normal supply or that product is orderable everywhere.
The public record does show:
- Omnipaque 100 mL recall. FDA records D-0447-2026 and D-0448-2026 cover 29 lots, Class II, begun in March 2026, and both were marked Ongoing in enforcement data updated Oct. 21.
- Optiray recall. FDA record D-0773-2026 is a Class I recall of one lot of Optiray Imaging Bulk Package-350, begun July 31, 2026 and also marked Ongoing. It is one lot of 3,486 vials and does not show a supply problem by itself.
- GE HealthCare's capacity remark. Answering a question about generic Omnipaque on the Oct. 28 earnings call, CEO Peter Arduini said, per The Motley Fool's transcript, that capacity in this market is at its limit, with demand and supply about equal and close to the limit in some quarters and months. He did not describe allocation. This is a company view, not a supply audit.
- American College of Radiology notice. ACR's May 21 notice cited industry reports that production was essentially normal, but said higher-than-usual ordering may be contributing to site-level variability and distributors might still be allocating. No later update was found.
- Guerbet. The company's Oct. 22 release reported Americas sales stable in Q3 and said it still expects normal batch release levels at its Raleigh, NC site at the end of the financial year.
- Hengrui discontinuations. FDA lists gadoterate meglumine and gadobutrol single-dose vials from Jiangsu Hengrui as To Be Discontinued.
No public source reviewed for this update gives October 2026 NDC-level availability or allocation for Omnipaque or Dotarem.
Is Omnipaque discontinued, or just difficult to source?
No public source says Omnipaque is discontinued. GE HealthCare's largest Omnipaque label file lists 59 NDCs, though a listing does not show stock. Amneal also has a generic: it says its 300 mg/mL 100 mL presentation has launched and that more presentations were approved in July with a planned Q3 2026 launch. That launch could not be confirmed.
Public sources cannot say at the NDC level whether a specific item is hard to source. The most concrete example is dated. Catholic Health in Buffalo adjusted selected non-emergency outpatient contrast CT scheduling from May 11, while protecting emergency and urgent studies, and tied the constraint to a recall by a manufacturer it did not name. It said that manufacturer expected improvement within weeks. No later status was found, and this is one system at one point in time.
An Ongoing recall status is not a shortage signal by itself. FDA does not explain the field, and it does not show that recalled stock remains in use or that supply is short. GE said in May that the supplier issue was resolved.
The discontinuations FDA lists are in MRI contrast, not Omnipaque. FDA's records do not name Dotarem or any Guerbet product. Buyers will see the Hengrui gadoterate under the Fresenius Kabi name, because the Fresenius label covers the same four NDCs FDA lists. A separate Fresenius label for NDC 65219-088 does not appear in FDA's discontinuation records. For gadobutrol, FDA limits the discontinuation to single-dose vials and says the 30 mL and 65 mL imaging bulk packages are to remain in supply.
What is causing the supply concerns?
There is no single public cause.
Omnipaque bottles. FDA states the reason as particulate matter. WHO, citing Ireland's HPRA, described metallic particulate in 100 mL polypropylene bottles and said glass containers were not affected. All 29 FDA lots appear in WHO's batch annexes, a comparison made for this article; WHO's alert does not mention the US. Radiology Business reported in May that GE attributed the defect to a manufacturing issue at an unnamed bottle supplier and moved to a second supplier. The same report said no adverse events were tied to the bottles and that injected particulates could cause life-threatening embolic events.
Demand. ACR cited higher-than-usual ordering in May. On the Oct. 28 call, Arduini said GE's scan and contrast-use data had not shown procedures declining.
Optiray lot. The company announcement published by FDA gives particulate matter as the reason, with no root cause and no supply impact stated.
Guerbet and Raleigh. Guerbet's H1 results release expects normal operations at Raleigh throughout fiscal 2027 and says the site is preparing for a new FDA inspection from the end of fiscal 2026. Its H1 revenue release cited short-term availability pressure on unnamed products in the Americas and a decline in Dotarem volumes, but it does not say Raleigh caused either one, so any link is inference. The later results release points to export-market Dotarem sales. The Dotarem label lists Guerbet subsidiary Liebel-Flarsheim, its Raleigh firm, for syringes and vials and Recipharm for vials, so vials have a second listed manufacturer.
Hengrui products. FDA's data gives no reason for the gadoterate or gadobutrol discontinuations, and no public cause was found.
Tariffs and gadolinium. No source reviewed ties tariffs or gadolinium raw material to a 2026 US contrast supply problem. That is not proof of no effect.
Which products and presentations are affected?
The table below covers the items with specific public facts. A recall entry applies to the listed lots, not to the whole NDC or brand.
| Product | NDC | Manufacturer | Status as of Oct. 30, 2026 |
|---|---|---|---|
| Omnipaque 300 mg iodine/mL, 10 x 100 mL plastic bottle | 00407-1413-63 | GE HealthCare | FDA recall D-0447-2026, Class II, 18 specific lots, marked Ongoing (data updated Oct. 21). No FDA shortage record. |
| Omnipaque 350 mg iodine/mL, 10 x 100 mL plastic bottle | 00407-1414-91 | GE HealthCare | FDA recall D-0448-2026, Class II, 11 specific lots, marked Ongoing (data updated Oct. 21). No FDA shortage record. |
| Other Omnipaque presentations | Labeler 00407 | GE HealthCare | No FDA shortage record and no open recall entry in FDA data (queried Oct. 30, 2026). No public NDC-level availability. |
| Generic iohexol 300 and 350 mg iodine/mL, 50, 75 and 100 mL | 80830-2466, -2467, -2468; 80830-2471, -2472, -2473 | Amneal | Amneal says the 300 mg/mL 100 mL presentation has launched. Launch of the other presentations is not confirmed. |
| Optiray Imaging Bulk Package-350 (ioversol 74%), 500 mL vial | 00019-1333-65 | Liebel-Flarsheim (Guerbet) | FDA recall D-0773-2026, Class I, lot 25ZF3670 only, marked Ongoing. No FDA shortage record. |
| Dotarem (gadoterate meglumine), vials, bottles, syringes and bulk | Labeler 67684 | Guerbet | No FDA shortage record and no recall entry found in FDA data (queried Oct. 30, 2026). No public NDC-level availability. |
| Gadoterate meglumine 376.9 mg/mL | 65219-0080-05, 65219-0082-10, 65219-0084-15, 65219-0086-20 | Jiangsu Hengrui, marketed by Fresenius Kabi | FDA: To Be Discontinued (records dated May 21 and June 30, 2026). No reason given. |
| Gadobutrol 604.72 mg/mL, single-dose vials | 65219-0281-02, 65219-0281-07, 65219-0281-10, 65219-0281-15 | Jiangsu Hengrui, marketed by Fresenius Kabi | FDA: To Be Discontinued (June 30, 2026). No reason given. |
| Gadobutrol imaging bulk packages, 30 mL and 65 mL | Not stated in the FDA note | Jiangsu Hengrui, marketed by Fresenius Kabi | FDA's June 30 note says these are to remain in supply. |
How is this affecting healthcare buyers and facilities?
- FDA status may not match purchasing experience. Omnipaque has no FDA listing, yet ACR noted possible allocation and site-level variability in May and GE's CEO described a market at its capacity limit in October. Any link to what a given buyer can order today is inference.
- Recall checks that still apply. Expiry dates on the recalled Omnipaque lots run into 2028 and 2029, so any affected stock would not age out on its own. FDA's record does not state the recall depth.
- Scheduling exposure. Catholic Health's May adjustment shows a constraint can reach outpatient CT scheduling. No reports from July to October 2026 were found.
- No near-term capacity date. GE's Cork expansion, announced in January 2025, targets 25 million more patient doses a year by end-2027, and current progress was not verified. Radiology Business says Bracco gave no construction timeline or start of operations for its $230 million Sanford, NC plant.
What should facilities do when supply is tight?
- Check on-hand stock against the lot lists. Compare Omnipaque 100 mL plastic bottles with the 29 FDA lots and confirm any required action with GE HealthCare. For Optiray lot 25ZF3670, the announcement tells facilities to stop use, quarantine and return the lot.
- Manage the category by NDC, container and package size. GE said in May that most demand was being met with unaffected SKUs. Container or package changes depend on current availability and contract terms.
- Confirm what is shipping, not just what is labeled. DailyMed lists other gadoterate labels, including Clariscan and Slate Run, and other gadobutrol labels, including Gadavist, Pixxoscan, Viwit, Zydus and Slate Run. A label shows that a product was listed, not that stock is available.
- Order to patient need. ACR asked providers not to build reserve stock, because over-ordering can worsen allocation, and to contact their contrast sales representative about order problems.
- Use pharmacy and governance controls. Any substitution, concentration change or protocol change belongs with radiology, pharmacy and P&T leadership and the product labeling.
Where can buyers monitor supply information through PRN?
PRN can help facilities source and plan as these items develop. Start with the Drug Shortage News hub, use the drug shortage index and High-Demand Products, and review the FAQ.
If your team needs sourcing support for a specific NDC or package size, use Request a Custom Quote. New facilities can start account setup through customer onboarding.
Need help planning around contrast media supply? Request a Custom Quote for sourcing support by NDC or package size, or start customer onboarding if your facility needs a purchasing account.
Important note: This article is intended for general informational and procurement reference only. It is not medical, legal, or regulatory advice. Facilities should confirm current recall status, shortage status, labeling, lot applicability, interchangeability, and purchasing decisions through current manufacturer, distributor, FDA, pharmacy, and institutional review channels before acting.