Class II recall covers 12 lots of widely used contrast agent distributed nationwide.
GE Healthcare Ireland Limited initiated a Class II recall of Omnipaque (iohexol) Injection 350 mg/mL due to presence of particulate matter. The recall covers 306,810 vials across 12 lot numbers distributed nationwide, with expiration dates ranging from November 2028 to January 2029. FDA classified the recall on April 9, 2026.
Sources
FDA Class II Recall: GE Healthcare 306k Iohexol Vials
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