FDA recall D-0447-2026

GE Healthcare Ireland Limited · Class II · drug

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.

Reason for recall

Presence of particulate matter

Distribution

U.S. Nationwide.

Key facts

Status: Ongoing
Initiation date: 2026-03-24
Report date: 2026-04-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Carrigtwohill, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2026