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

[pending] OMNIPAQUE (IOHEXOL)

Pending LLM rewrite. Source: FDA_DRUG D-0448-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

Presence of particulate matter

The recalled product

Product
OMNIPAQUE (IOHEXOL)
Brand
OMNIPAQUE
Manufacturer
GE Healthcare Ireland Limited

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.