The Recall Desk
HighFDA (Drugs)·D-0448-2026·Announced 2026-04-15

GE Healthcare Omnipaque 350 contrast injection recalled for particulate matter

GE Healthcare is recalling Omnipaque (iohexol) Injection, 350 mg/mL, over the presence of particulate matter. The action covers 306,810 vials distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of an injectable contrast agent containing particulate matter, a risk of harm with no injuries reported in the source.

Plain-English summary

GE Healthcare Ireland Limited is recalling Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), NDC 0407-1414-91. The action covers 306,810 vials.

The stated reason is the presence of particulate matter. Omnipaque is an injectable radiographic contrast agent, and particulate matter in an injectable product is a recognised quality defect. The FDA classified the action as Class II.

Multiple lot numbers are affected, listed in the recall notice with expiry dates running into 2029. Distribution was US nationwide.

This is a prescription product supplied to healthcare facilities. Facilities should check stock against the lot numbers in the recall notice, quarantine affected vials and follow the instructions issued by GE Healthcare.

The recalled product

Product
OMNIPAQUE (IOHEXOL)
Brand
OMNIPAQUE
Manufacturer
GE Healthcare Ireland Limited
Category
Drug — Contrast agent
Hazard
Affected units
306,810

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 2029 Lot# 17426440
  • Exp. January 4
  • 2029 Lot# 17431310

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare Ireland Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · OMNIPAQUE

Same hazard · particulate matter

See all →