FDA-Drug2026-04-15Class IIPROCESSING DEFECT
GE Healthcare Omnipaque iohexol injection recalled for particulate matter
Nationwide distributionDrugs
What this means
GE Healthcare has recalled specific lots of Omnipaque (iohexol) injection, a contrast dye used in medical imaging, because some vials may contain visible particles. This could affect the safety of the procedure if the contaminated solution is used.
- If you work in a hospital or imaging facility, check your inventory against the 16 affected lot numbers listed in the recall notice
- Do not use any vials from the recalled lots, even if they appear clear to the eye
- Contact GE Healthcare or the FDA if you have questions about specific lot numbers
The agency's original wording
Hazard
Presence of particulate matter
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide.
Affected count
866,570 vials
Manufactured in
Ida Business Park, Carrigtwohill, Ireland
Products
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2026Want us to check the next one for you?
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