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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Omnipaque (iohexol) Injection Recalled for Particulate Matter

Agency Publication Date: April 9, 2026
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Summary

GE Healthcare Ireland Limited is recalling approximately 1,173,380 vials of Omnipaque (iohexol) Injection, a contrast agent used in medical imaging, due to the presence of particulate matter in certain batches. Using an injectable medication containing foreign particles can lead to serious health complications, such as blood clots or inflammation. No injuries have been reported to date, but the company has initiated this voluntary recall for 29 specific lots distributed nationwide to hospitals and clinics.

Risk

The presence of particulate matter in an injectable drug can cause local irritation, inflammation, or the blockage of blood vessels, which could lead to serious medical events like a stroke or pulmonary embolism. If you have received this injection and have health concerns, contact your healthcare provider immediately.

What You Should Do

  1. Identify if you have the affected Omnipaque (iohexol) Injection by checking the product strength, NDC code, and lot number on the vial or carton.
  2. For the 300 mg/mL strength (NDC 0407-1413-63), check for 18 specific lot numbers including 17225029, 17265376, and 17270885. See the Affected Products section below for the full list of affected codes.
  3. For the 350 mg/mL strength (NDC 0407-1414-91), check for 11 specific lot numbers including 17333197, 17333198, and 17396945. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Omnipaque (iohexol) Injection, 300 mg/mL (64.7%)
Variants: 300 mg/mL, Injection
Lot Numbers:
17225029 (Exp. September 3, 2028)
17265376 (Exp. October 3, 2028)
17270885 (Exp. September 10, 2028)
17292246 (Exp. October 4, 2028)
17301805 (Exp. October 18, 2028)
17301807 (Exp. September 7, 2028)
17301810 (Exp. October 20, 2028)
17304992 (Exp. October 5, 2028)
17304993 (Exp. October 19, 2028)
17304996 (Exp. November 25, 2028)
17321225 (Exp. September 8, 2028)
17333589 (Exp. November 24, 2028)
17333611 (Exp. November 26, 2028)
17333613 (Exp. November 23, 2028)
17357000 (Exp. December 5, 2028)
17366399 (Exp. December 14, 2028)
17376486 (Exp. December 14, 2028)
17404114 (Exp. December 6, 2028)
NDC:
0407-1413-63

Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA. Total quantity: 866,570 vials.

Product: Omnipaque (iohexol) Injection, 350 mg/mL (64.7%)
Variants: 350 mg/mL, Injection
Lot Numbers:
17333197 (Exp. December 10, 2028)
17333198 (Exp. November 17, 2028)
17396945 (Exp. December 18, 2028)
17396948 (Exp. December 22, 2028)
17396953 (Exp. January 11, 2029)
17396956 (Exp. January 9, 2029)
17423503 (Exp. January 1, 2029)
17423525 (Exp. January 3, 2029)
17426429 (Exp. January 1, 2029)
17426440 (Exp. January 4, 2029)
17431310 (Exp. January 11, 2029)
NDC:
0407-1414-91

Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA. Total quantity: 306,810 vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98656
Status: Active
Manufacturer: GE Healthcare Ireland Limited
Sold By: Hospitals; Medical Clinics; Imaging Centers; Pharmacies
Manufactured In: Ireland
Units Affected: 1,173,380
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.