Class II U.S. Food and Drug Administration

GE Healthcare Ireland Limited GE Healthcare Omnipaque Injection, 300 mg/mL recall: Presence of particulate matter

Recall published 6 months ago

Presence of particulate matter

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Presence of particulate matter

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0447-2026
Published
April 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Healthcare Ireland Limited
Product type
Prescription & OTC drugs
Units affected
866,570 vials
Distribution
Nationwide
Made in
Ireland
Lot / code info
Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028

Products covered by this recall

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.

Check your product

The notice names 40 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 17225029
  • 17265376
  • 17270885
  • 17292246
  • 17301805
  • 17301807
  • 17301810
  • 17304992
  • 17304993
  • 17304996
  • 17321225
  • 17333589
  • 17333611
  • 17333613
  • 17357000
  • 17366399
  • 17376486
  • 17404114

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • September 3
  • 2028 Lot# 17265376
  • October 3
  • 2028 Lot# 17270885
  • September 10
  • 2028 Lot# 17292246
  • October 4
  • 2028 Lot# 17301805
  • October 18
  • 2028 Lot# 17301807
  • September 7
  • 2028 Lot# 17301810
  • October 20
  • 2028 Lot# 17304992
  • October 5
  • 2028 Lot# 17304993
  • October 19
  • 2028 Lot# 17304996
  • November 25
  • 2028 Lot# 17321225

NDC number

On the carton and again on the bottle or blister label.

  • 0407-1413-63

Package size

Match the net weight or the piece count on the front of the pack.

  • 300 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

GE Healthcare Ireland Limited — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: GE Healthcare Ireland Limited — Ida Business Park, Carrigtwohill

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Healthcare Ireland Limited prescription & otc drugs recalled?

Presence of particulate matter Presence of particulate matter

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 17225029, 17265376, 17270885; best-by date September 3 or 2028 Lot# 17265376. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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