GE Healthcare Ireland Limited recalls GE Healthcare Omnipaque
- Recalling company
- GE Healthcare Ireland Limited
- Product
- 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.
- Reason
- Presence of particulate matter
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 24, 2026
- Reported
- Apr 15, 2026
- Distribution
- U.S. Nationwide.
- Status
- Ongoing
- Quantity
- 306,810 vials
- Lot / codes
- 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
- Company location
- Carrigtwohill
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0448-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0448-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.