GE Healthcare Omnipaque 180mg Injection Recall: Container Defect Risk
GE Healthcare recalls Omnipaque 180mg injection vials due to potential container defects that could compromise sterility and cause glass particles. Affected products include specific lot numbers and packaging.
Lower-risk recall
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Contact the company
What happened, in plain English
GE Healthcare is recalling Omnipaque 180mg injection vials because a defect in the container might lead to contamination or glass particles. This could pose a risk to patient safety during medical procedures. Read more at govinfonow.com/recall/39461-ge-healthcare-omnipaque-180mg-injection-recall-container-defect-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39461-ge-healthcare-omnipaque-180mg-injection-recall-container-defect-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0319-2019
Cite this page
“GE Healthcare Omnipaque 180mg Injection Recall: Container Defect Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39461-ge-healthcare-omnipaque-180mg-injection-recall-container-defect-risk. Based on FDA recall #D-0319-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0319-2019%22&limit=1).
Why it’s dangerous
The vial container defect could allow contamination or glass particles to enter the injection solution. This might lead to infections or other complications if the product is used improperly.
Who’s affected
Patients prescribed Omnipaque injections by healthcare providers in the U.S. are affected. Those using the specific lot numbers and packaging described in the recall are most at risk.
How to tell if you have this one
Check for Omnipaque 180mg injection vials (20mL single-dose) packaged in sets of 10 vials per carton. The lot number 14301544 with expiration date September 21, 2021, is affected.
- Brand
GE Healthcare- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the vial packaging to confirm if it matches the recalled batch.
Where it went and when
Where it was distributed
Distributed in Tennessee.
FDA distribution: “TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0319-2019 (October 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0319-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.