Quick Facts at a Glance
- Recall Date
- March 24, 2026
- Hazard Level
- HIGH
- Brands
- OMNIPAQUE, GE Healthcare Inc.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- OMNIPAQUE, GE Healthcare Inc.
- Product type
- Intravenous contrast injection
- Model numbers
- Lot# 17333197, Exp. December 10, 2028 Lot# 17333198, Exp. November 17, 2028 Lot# 17396945, Exp. December 18, 2028 Lot# 17396948, Exp. December 22 +12 more
- UPC codes
- 0407-1401, 0407-1411, 0407-1412, 0407-1413, 0407-1414, 0407-1415, 0407-1416, 0407-1401-52 +9 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 24, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of particulate matter
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact GE Healthcare Ireland Limited or your healthcare provider for guidance
About This Product
Omnipaque iohexol is a contrast agent used in imaging procedures to enhance visibility of internal structures.
Why This Is Dangerous
Particulate matter in an injectable solution can pose risks during administration and may affect safety and imaging results.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
It may cause procedure delays and requires clinician coordination for safe alternatives.
Practical Guidance
How to identify if yours is affected
- Check NDC 0407-1414-91 on vial label.
- Review lot numbers listed in recall documentation.
- Verify expiration dates from 2028 to 2029.
Where to find product info
FDA recall page D-0448-2026 and GE Healthcare recall notices.
What timeline to expect
Hospitals may take 4-8 weeks for full remedy implementation.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Request assistance from GE Healthcare Ireland Limited.
- Contact FDA Consumer Complaint Coordinators if necessary.
How to prevent similar issues
- Confirm product integrity before administration.
- Coordinate with pharmacy to use alternatives if contamination is suspected.
- Maintain updated recall communications with healthcare providers.
Documentation advice
Keep recall notices, lot numbers, and correspondence with manufacturers and regulators.
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Product Details
Brand: OMNIPAQUE. Distributor: GE Healthcare Inc., Marlborough, MA. NDC: 0407-1414-91. Formulation: iohexol injection, 350 mg/mL (64.7%). Quantity: 306,810 vials. Route: Intravenous. Status: ACTIVE recall. Recall date: 2026-03-24.
Reported Incidents
No incident counts are provided in the data. The recall status is active with a high hazard level.
Key Facts
- Exp. dates range from 2028 to 2029
- Distributed nationwide in the U.S.
- Hazard: particulate matter in injection
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Safety Guide
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