Recall of GE Healthcare's Omnipaque Injection Due to Particulate Matter

Source: FDA · United States

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GE Healthcare is voluntarily recalling 306,810 vials of Omnipaque injection across multiple lots due to the presence of particulate matter, affecting products distributed nationwide in the U.S.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

GE Healthcare is recalling certain lots of Omnipaque injection because of the presence of particulate matter, which was identified as the reason for this voluntary recall initiated by the firm.

Which Products Are Affected

The affected products are GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL, with the following lot numbers and expiration dates: 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# 17396953 (Exp. January 11, 2029), Lot# 17396956 (Exp. January 9, 2029), Lot# 17423503 (Exp. January 1, 2029), Lot# 17423525 (Exp. January 3, 2029), Lot# 17426429 (Exp. January 1, 2029), Lot# 17426440 (Exp. January 4, 2029), and Lot# 17431310 (Exp. January 11, 2029). A total of 306,810 vials are affected, distributed in the U.S. nationwide. The product is a human prescription drug with NDC codes such as 0407-1414-91.

What You Should Do

Consumers and healthcare providers in possession of the affected lots should contact the recalling firm, GE Healthcare Ireland Limited, for instructions on returns or further actions related to this recall.

Why This Matters

This recall involves a prescription drug used for medical imaging, and the presence of particulate matter could pose potential risks to patient safety, highlighting the importance of quality control in pharmaceutical products.

Source

FDA Recall Number: D-0448-2026. For more information, refer to the FDA website at https://www.fda.gov/.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
GE Healthcare is voluntarily recalling 306,810 vials of Omnipaque injection across multiple lots due to the presence of particulate matter, affecting products distributed nationwide in the U.S.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.