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DRUG RECALLMODERATE
Omnipaque (iohexol) Injection 350 mg/mL
GE Healthcare recalls Omnipaque 350 mg/mL injection due to particulate matter.
What to do
Do not use the affected product. Contact GE Healthcare for instructions on returning the recalled lot and obtaining a replacement.
Why it was recalled
GE Healthcare is recalling Omnipaque (iohexol) Injection, 350 mg/mL, due to the presence of particulate matter in the product. Administration of the affected contrast agent may cause adverse health effects.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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. | 17333197, 17333198, 17396945, 17396948, 17396953, 17396956, 17423503, 17423525, 17426429, 17426440, 17431310 | D-0448-2026 |
| 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. | 17225029, 17265376, 17270885, 17292246, 17301805, 17301807, 17301810, 17304992, 17304993, 17304996, 17321225, 17333589, 17333611, 17333613, 17357000, 17366399, 17376486, 17404114 | D-0447-2026 |
Where it was sold
Distributed nationwide.
Official source
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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification