Quick Facts at a Glance
- Recall Date
- March 24, 2026
- Hazard Level
- HIGH
- Brands
- OMNIPAQUE, GE Healthcare Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Injection
- Model numbers
- Lot# 17225029, Exp. September 3, 2028 Lot# 17265376, Exp. October 3, 2028 Lot# 17270885, Exp. September 10, 2028 Lot# 17292246, Exp. October 4 +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
- Multiple Retailers
- 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 injection is a contrast agent used in radiologic imaging. It helps visualize blood vessels and tissues during CT or fluoroscopy.
Why This Is Dangerous
The product contains particulate matter which can cause injection-related complications depending on the material and sterility.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must identify affected lots, quarantine them, and follow disposal protocols. No user-level consumer data provided.
Practical Guidance
How to identify if yours is affected
- Review lot numbers and expiry dates against the recall list
- Check NDC 0407-1413-63 on packaging
- Inspect vials for particulates during handling
- Quarantine affected inventory immediately
Where to find product info
FDA enforcement report D-0447-2026 and GE Healthcare recall communications
What timeline to expect
Facilities may take 4-6 weeks for disposition or replacement of affected lots
If the manufacturer is unresponsive
- Escalate to institutional recall coordinator
- Contact GE Healthcare regional office for escalation
- Consult FDA for further guidance
How to prevent similar issues
- Establish strict inbound inspection for sterile injectables
- Verify NDC and lot/date codes before use
- Maintain separation of affected inventory from stock for quick quarantine
Documentation advice
Maintain lot lists, disposal records, and correspondence with GE Healthcare
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Product Details
Brand: OMNIPAQUE (iohexol). Distributor: GE Healthcare Inc., Marlborough, MA. NDC: 0407-1413-63. Quantity: 866,570 vials. Formulation: 300 mg/mL (64.7%). Route: Injectable Rx only. Sold nationwide in the U.S. via healthcare supply channels. Expiry dates mentioned in lot details (e.g., Exp. Sept 3 2028, Exp. Oct 3 2028, etc.). Lot numbers listed in safety notice.
Reported Incidents
No specific consumer injury or adverse event data provided in the recall notice.
Key Facts
- Particulate matter detected
- Distributed nationwide in the U.S.
- Lots with expiry in 2028 (Sept 3, Oct 3, Oct 18, Oct 20, Oct 4, Oct 5, Oct 19, Nov 25)
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Safety Guide
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