FDAFDA · Food and drugs·Recall number D-0448-2026
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.
Published April 15, 2026 · Recall initiated: March 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter
What to do
Voluntary: Firm initiated
Recall details
- Brand
- OMNIPAQUE
- Manufacturer
- GE Healthcare Ireland Limited
- Distributor
- U.S. Nationwide.
- Lot
- Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Ireland
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