Reported Apr 15, 2026 · Ongoing

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc.,…

GE Healthcare Ireland Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare Ireland Limited · Ida Business Park · Carrigtwohill · N/A

Is this the product you have?

  • GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only
  • Distributed byGE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91
Lot codes and dates

12 of 12 products

Products covered by this recall
#Product as published
1Lot# 17333197
2Exp. December 10, 2028 Lot# 17333198
3Exp. November 17, 2028 Lot# 17396945
4Exp. December 18, 2028 Lot# 17396948
5Exp. December 22, 2028 Lot# 17396953
6Exp. January 11, 2029 Lot# 17396956
7Exp. January 9, 2029 Lot# 17423503
8Exp. January 1, 2029 Lot# 17423525
9Exp. January 3, 2029 Lot# 17426429
10Exp. January 1, 2029 Lot# 17426440
11Exp. January 4, 2029 Lot# 17431310
12Exp. January 11, 2029
Amount recalled
306,810 vials

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Presence of particulate matter

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new GE Healthcare Ireland Limited recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.