GE Healthcare Ireland Limited recalls GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough
Recalled April 15, 2026 · FDA recall D-0448-2026 · GE Healthcare Ireland
Hazard
Presence of particulate matter · FDA Class II
Units
306,810 vials
Sold at
U.S. Nationwide.
Description
Presence of particulate matter
Product
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Manufacturer(s)
GE Healthcare Ireland Limited
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →