FDA · Drugs ·
GE Healthcare Omnipaque (iohexol) Injection recall
GE Healthcare Ireland Limited recalled GE Healthcare Omnipaque (iohexol) Injection on April 15, 2026 because of presence of particulate matter. It was sold nationwide.
Why it was recalled
Presence of particulate matter
What's recalled
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Quantity: 866,570 vials
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- GE Healthcare Ireland Limited, Carrigtwohill
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
U.S. Nationwide. - Status
- Ongoing
- Recall number
- D-0447-2026
- Source
- U.S. Food and Drug Administration
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