GE Healthcare Omnipaque iohexol injection recalled for particulate matter
GE Healthcare has recalled specific lots of Omnipaque (iohexol) injection, a contrast dye used in medical imaging, because some vials may contain visible particles. This could affect the safety of the procedure if the contaminated solution is used.
From the FDA notice · Read the official notice ↗ · All GE Healthcare recalls
What to do
- If you work in a hospital or imaging facility, check your inventory against the 16 affected lot numbers listed in the recall notice
- Do not use any vials from the recalled lots, even if they appear clear to the eye
- Contact GE Healthcare or the FDA if you have questions about specific lot numbers
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 866,570 vials
- Illnesses reported
- None reported
- Manufactured in
- Ida Business Park, Carrigtwohill, Ireland
- Classification
- Class II
- Recall number
- D-0447-2026
In the FDA's words
- Description
- 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. Presence of particulate matter 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 Distribution: U.S. Nationwide. Affected quantity: 866,570 vials
- Hazard
- Presence of particulate matter
2 products in this recall
The agency lists each product separately. Check every one you might have.
- 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. (this page)D-0447-2026 · 866,570 vials
- 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.D-0448-2026 · 306,810 vials