FDA-Drug2026-04-15Class IIPROCESSING DEFECT
GE Healthcare Omnipaque iohexol injection recalled for particulate matter contamination
Nationwide distribution
Check Omnipaque injection lot numbers immediately
GE Healthcare discovered particles in certain vials of Omnipaque (iohexol), a contrast dye used during medical imaging procedures. The contamination affects 11 specific lot numbers distributed nationwide. No injuries have been reported so far.
- If you have any of the affected lot numbers, stop using them and contact your healthcare provider or pharmacy
- Check the lot number and expiration date on your vials against the list provided by GE Healthcare
- Contact GE Healthcare or the FDA if you have questions about affected lots
Hazard
Presence of particulate matter
Sold states
U.S. Nationwide.
Affected count
306,810 vials
Manufactured in
Ida Business Park, Carrigtwohill, Ireland
Products
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2026More GE Healthcare Ireland Limited recalls
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