GE Healthcare recalled Omnipaque iohexol injection after discovery of particulate matter. The recall covers 306,810 vials distributed nationwide in the United States. WHS: Distributed by GE Healthcare Inc., Marlborough, MA. Consumers should stop use and consult a healthcare provider for guidance.
Presence of particulate matter
Consumers and healthcare providers should stop using this product immediately. Contact GE Healthcare Ireland Limited or your healthcare provider for guidance
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Omnipaque iohexol is a contrast agent used in imaging procedures to enhance visibility of internal structures.
Particulate matter in an injectable solution can pose risks during administration and may affect safety and imaging results.
This recall is not part of a broader industry pattern.
It may cause procedure delays and requires clinician coordination for safe alternatives.
FDA recall page D-0448-2026 and GE Healthcare recall notices.
Hospitals may take 4-8 weeks for full remedy implementation.
Keep recall notices, lot numbers, and correspondence with manufacturers and regulators.
Brand: OMNIPAQUE. Distributor: GE Healthcare Inc., Marlborough, MA. NDC: 0407-1414-91. Formulation: iohexol injection, 350 mg/mL (64.7%). Quantity: 306,810 vials. Route: Intravenous. Status: ACTIVE recall. Recall date: 2026-03-24.
No incident counts are provided in the data. The recall status is active with a high hazard level.
Not sure what to do next? Our guide walks you through the process step by step.
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