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Omnipaque (iohexol) Injection 350 mg/mL
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DRUG RECALLMODERATE

Omnipaque (iohexol) Injection 350 mg/mL

GE Healthcare recalls Omnipaque (iohexol) Injection 350 mg/mL due to particulate matter.

What to do

Consumers should stop using the recalled product and contact their healthcare provider or GE Healthcare for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
D-0448-2026
Agency
FDA
Firm
GE Healthcare Ireland Limited
Recall ID
98656
Status
ONGOING

Why it was recalled

GE Healthcare is recalling Omnipaque (iohexol) Injection, 350 mg/mL, due to the presence of particulate matter. The affected product is a contrast agent used for diagnostic imaging procedures.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

GE Healthcare Omnipaque (iohexol) Injection

StrengthUPCRecall #
350 mg17333197, 17333198, 17396945, 17396948, 17396953, 17396956, 17423503, 17423525, 17426429, 17426440, 17431310D-0448-2026
300 mg17225029, 17265376, 17270885, 17292246, 17301805, 17301807, 17301810, 17304992, 17304993, 17304996, 17321225, 17333589, 17333611, 17333613, 17357000, 17366399, 17376486, 17404114D-0447-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification