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Ultravist FDA Alerts

The FDA Alerts below may be specifically about Ultravist or relate to a group or class of drugs which include Ultravist.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Ultravist

Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. See the Drug Safety Communication for a data summary and a list of approved Approved Iodinated Contrast Media Products.

FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. FDA will continue to evaluate this issue and will update the public when there is additional information. Manufacturers of ICM products have been required to conduct a study to investigate this safety issue further.

BACKGROUND: Iodinated contrast media are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images such as X-rays or computed tomography (CT) scans. These images provide greater detail when necessary to help health care professionals diagnose potential problems.

RECOMMENDATION: Parents and caregivers should contact their baby’s health care professional for additional information or if they have questions or concerns about their baby receiving an ICM product. Infants typically do not show any visible signs of underactive thyroid. Health care professionals should continue to follow the label recommendations for ICM products. They should continue to use their clinical judgment to determine if testing for underactive thyroid is necessary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/17/2015 - Drug Safety Communication - FDA]

Ultravist (iopromide) Injection 370mgl/mL, 125 mL

[UPDATED 07/31/2006] Berlex, Inc. and FDA announced a voluntary worldwide recall of all lots of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, due to the presence of particulate matter and crystallization with the potential for thromboembolic safety problems if an affected product is administered to patients.

[Posted 07/21/2006] Berlex, Inc. and FDA announced a voluntary nationwide recall of a single lot (No. 41500A, Exp. 1/2007) of Ultravist (iopromide) Injection 370mgl/mL, 125 ml, an intravenous X-ray contrast agent, due to the presence of particulate matter in conjunction with crystallization. The product was recalled because of the potential for serious safety problems if Ultravist Injection is administered to patients. These problems may include thrombosis of blood vessels, thromboembolism and injury or infarction of end organs such as heart, kidney, and brain.

Hospitals, imaging centers and other healthcare facilities should not use any of the affected lot number (41500A) of Ultravist Injection 370mgL/mL, 125 mL for patient care and should immediately quarantine any product for return.

[July 31, 2006 - Press Release - Berlex]
[July 21, 2006 - Press Release - Berlex]

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