Why it was recalled
Presence of particulate matter
Product description
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.
Lot numbers, UPCs & expiration 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
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0448-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 24, 2026
- FDA report date
- Apr 15, 2026
- Quantity
- 306,810 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GE Healthcare Ireland Limited
Original FDA data
Every field from FDA enforcement report D-0448-2026, exactly as published.
Show all FDA fields
- City
- Carrigtwohill
- Status
- Ongoing
- Country
- Ireland
- Event ID
- 98656
- Address
- Ida Business Park
- Code information
- 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
- Report date
- Apr 15, 2026
- Product type
- Drugs
- Recall number
- D-0448-2026
- Classification
- Class II
- Recalling firm
- GE Healthcare Ireland Limited
- Product quantity
- 306,810 vials
- Reason for recall
- Presence of particulate matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Mar 24, 2026
- Center classification date
- Apr 9, 2026