Class II · Moderate risk
GE Healthcare Omnipaque
Presence of particulate matter
GE Healthcare Omnipaque (Iohexol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of particulate matter
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was 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.
Affected NDC
0407-1414-91
Compare with the code on your package — it is the most precise check available.
Drug: Iohexol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Omnipaque Iohexol NDC 00407-1414 |
350 mg/mL | Injection, Solution Intra-Articular|intravascular|intravenous|oral |
GE Healthcare Inc. | Rx |
- Recalling firm
- GE Healthcare Ireland Limited
- NDC code
- 0407-1414-91
- Origin
- Ireland
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0448-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Iohexol recalls
See all
Class I · High risk
Iohexol (300 mg Iodine/mL)
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class II · Moderate risk
Iohexol
Lack of Assurance of Sterility
Class II · Moderate risk
Omnipaque (iohexol)
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Class II · Moderate risk
Iopamidol 41% Injectable 198 Ml 99 Ml 50 Ml 600 Ml 72 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other recalls by GE Healthcare Ireland Limited
All 2026 recalls
Class II · Moderate risk
GE Healthcare Omnipaque
Presence of particulate matter
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