The Recall Desk
HighFDA (Drugs)·D-0447-2026·Announced 2026-04-15

OMNIPAQUE Radiographic Contrast Injection Recalled Nationwide for Particulate Matter

GE Healthcare is recalling OMNIPAQUE (iohexol) radiographic contrast injection nationwide due to the presence of particulate matter in certain lots. The recall affects 866,570 vials.

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: This is an FDA Class II recall for presence of particulate matter in a radiographic contrast agent administered intravascularly or intravenously. Although no illnesses or injuries are reported in the source material, the presence of particles in an injectable drug administered directly into the bloodstream represents a documented risk-of-harm scenario. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

GE Healthcare Inc. is recalling OMNIPAQUE (iohexol) radiographic contrast injection, 300 mg/mL, due to the presence of particulate matter in certain lots. The product is manufactured by GE Healthcare Ireland Limited and distributed by GE Healthcare Inc., located in Marlborough, Massachusetts.

The recall involves 866,570 vials distributed nationwide across 18 specific lot numbers. The affected lots have expiration dates ranging from September 2028 to December 2028.

OMNIPAQUE is a radiographic contrast agent administered intravascularly or intravenously for diagnostic imaging procedures.

The recalled product

Product
OMNIPAQUE (IOHEXOL)
Brand
OMNIPAQUE
Manufacturer
GE Healthcare Ireland Limited
Category
Drug — Radiographic Contrast Agent
Hazard
  • particulate-matter

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# 17225029
  • Exp. September 3
  • 2028 Lot# 17265376
  • Exp. October 3
  • 2028 Lot# 17270885
  • Exp. September 10
  • 2028 Lot# 17292246
  • Exp. October 4
  • 2028 Lot# 17301805
  • Exp. October 18
  • 2028 Lot# 17301807
  • Exp. September 7
  • 2028 Lot# 17301810
  • Exp. October 20
  • 2028 Lot# 17304992
  • Exp. October 5
  • 2028 Lot# 17304993
  • Exp. October 19
  • 2028 Lot# 17304996
  • Exp. November 25

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · OMNIPAQUE

Same category