Recall RadarGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Presence of particulate matter
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- GE Healthcare Ireland Limited — Carrigtwohill
- Severity
- Class II — moderate
- Reported
- April 15, 2026
- Quantity
- 306,810 vials
- Recall number
- D-0448-2026
- Status
- Ongoing
- Source
- FDA
Where it went
U.S. Nationwide.
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