Recall: D-0448-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-24Initiated

OngoingStatus

GE Healthcare Ireland LimitedFirm

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.

Reason

Presence of particulate matter

Distribution

U.S. Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.