FDA recall, , Moderate risk
GE Healthcare Omnipaque (Iohexol) Injection
GE Healthcare Omnipaque (iohexol) Injection contains particulate matter.
Summary by Recall Canary from the FDA notice
What happened
GE Healthcare Ireland Limited is recalling GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%) and 300 mg/mL (64.7%), distributed by GE Healthcare Inc., Marlborough, MA 01752 USA, due to the presence of particulate matter. The recall began March 24, 2026, and was added to the FDA's Enforcement Report on April 9, 2026. The products were distributed nationwide in the U.S.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UPC is the number printed under a barcode.
GE Healthcare Omnipaque (iohexol) Injection
- Strength
- 350 mg/mL
- UPC
- 17333197
- 17333198
- 17396945
- 17396948
- 17396953
- 17396956
- 17423503
- 17423525
- 17426429
- 17426440
- 17431310
- Strength
- 300 mg/mL
- UPC
- 17225029
- 17265376
- 17270885
- 17292246
- 17301805
- 17301807
- 17301810
- 17304992
- 17304993
- 17304996
- 17321225
- 17333589
- 17333611
- 17333613
- 17357000
- 17366399
- 17376486
- 17404114
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
U.S. Nationwide.
- Company
- GE Healthcare Ireland LimitedCarrigtwohill, Ireland
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98656
- Recall numbers
- D-0447-2026 to D-0448-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
