Class II · ModerateActive recall
Omnipaque
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot# 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 soldU.S. Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of particulate matter
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGE Healthcare Inc.
| Brand name | OMNIPAQUE |
| Generic name | IOHEXOL |
| Active ingredient(s) | IOHEXOL |
| Distributed by / for | GE Healthcare Inc., Marlborough, MA 01752 USA |
| NDC | 0407-1414-91 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | GE Healthcare Ireland Limited |
| Distribution | U.S. Nationwide. |
| Quantity | 306,810 vials |
| Recall initiated | 2026-03-24 |
| Report date | 2026-04-15 |
| Recall completed | — |
| Recall number | D-0448-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Carrigtwohill Ireland |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.