Warning
GE Healthcare Ireland Limited Recalls GE Healthcare Omnipaque (iohexol) Injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0447-2026Drug / Pharmaceutical
GE Healthcare Ireland Limited Recalls GE Healthcare Omnipaque (iohexol) Injection
GE Healthcare Ireland Limited · Class II — Moderate Risk
Product Description
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Reason for Recall
Presence of particulate matter
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
GE Healthcare Ireland Limited has recalled a pharmaceutical product that the FDA classified as Class II affecting 866,570 vials. The recall was initiated on March 24, 2026. Presence of particulate matter. It was distributed in U.S. Nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.