GE Healthcare Omnipaque (iohexol) Injection recall — Class II (D-0447-2026) · pharmaranks
Class IIOngoing
GE Healthcare Omnipaque (iohexol) Injection recall
FDA recall D-0447-2026 · initiated Mar 24, 2026
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter
Details
Product
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.
Recalling company
GE Healthcare Ireland Limited
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
U.S. Nationwide.
Initiated
Mar 24, 2026
FDA report date
Apr 15, 2026
This recall is linked to a product we cover: Omnipaque 180 →
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.