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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, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Quantity: 306,810 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 notice

Details

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-0448-2026
Source
U.S. Food and Drug Administration

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