GE Healthcare recalled Omnipaque iohexol injection, 300 mg/mL, distributed nationwide in the United States. The Class II recall covers 866,570 vials due to particulate matter. Healthcare providers should stop use and contact GE Healthcare Ireland Limited 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 injection is a contrast agent used in radiologic imaging. It helps visualize blood vessels and tissues during CT or fluoroscopy.
The product contains particulate matter which can cause injection-related complications depending on the material and sterility.
This recall is not part of a broader industry pattern.
Hospitals and clinics must identify affected lots, quarantine them, and follow disposal protocols. No user-level consumer data provided.
FDA enforcement report D-0447-2026 and GE Healthcare recall communications
Facilities may take 4-6 weeks for disposition or replacement of affected lots
Maintain lot lists, disposal records, and correspondence with GE Healthcare
Brand: OMNIPAQUE (iohexol). Distributor: GE Healthcare Inc., Marlborough, MA. NDC: 0407-1413-63. Quantity: 866,570 vials. Formulation: 300 mg/mL (64.7%). Route: Injectable Rx only. Sold nationwide in the U.S. via healthcare supply channels. Expiry dates mentioned in lot details (e.g., Exp. Sept 3 2028, Exp. Oct 3 2028, etc.). Lot numbers listed in safety notice.
No specific consumer injury or adverse event data provided in the recall notice.
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