GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%)

GE Healthcare Ireland Limited has recalled GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 15, 2026 and was initiated on March 24, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), with approximately 306,810 vials affected. The company behind the recall is GE Healthcare Ireland Limited, based in Carrigtwohill. The FDA describes the product as: “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.”

Why was GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%) recalled?

According to the FDA, the stated reason for the recall is: “Presence of particulate matter.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), compare it against the product description and identifying codes (Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17…) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact GE Healthcare Ireland Limited or your local health authority.

About this recall

This recall was distributed in U.S. Nationwide.. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.