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Drug FDA Class II Ongoing Foreign material

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

GE Healthcare Ireland Limited Published Apr 15, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact GE Healthcare Ireland Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of particulate matter

Hazards

Particulate Matter · primary

Affected products (1)

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

OMNIPAQUE · 866,570 vials

NDC: 0407-1401, 0407-1411, 0407-1412, 0407-1413, 0407-1414, 0407-1415, 0407-1416, 0407-1401-52, 0407-1411-10, 0407-1411-20, 0407-1412-10, 0407-1412-20, 0407-1412-50, 0407-1412-29, 0407-1412-30, 0407-1412-60, 0407-1412-33, 0407-1412-27, 0407-1412-49, 0407-1412-34, 0407-1412-28, 0407-1412-35, 0407-1413-11, 0407-1413-10, 0407-1413-59, 0407-1413-30, 0407-1413-50, 0407-1413-51, 0407-1413-61, 0407-1413-95, 0407-1413-98, 0407-1413-62, 0407-1413-99, 0407-1413-60, 0407-1413-63, 0407-1413-91, 0407-1413-53, 0407-1413-90, 0407-1413-65, 0407-1413-92, 0407-1413-66, 0407-1413-93, 0407-1413-96, 0407-1413-69, 0407-1414-21, 0407-1414-50, 0407-1414-51, 0407-1414-52, 0407-1414-89, 0407-1414-20, 0407-1414-90, 0407-1414-22, 0407-1414-53, 0407-1414-60, 0407-1414-91, 0407-1414-76, 0407-1414-03, 0407-1414-23, 0407-1414-93, 0407-1414-04, 0407-1414-94, 0407-1414-24, 0407-1414-80, 0407-1414-95, 0407-1415-09, 0407-1416-12
Lot codes: 17225029, 17265376, 17270885, 17292246, 17301805, 17301807, 17301810, 17304992, 17304993, 17304996, 17321225, 17333589, 17333611, 17333613, 17357000, 17366399, 17376486, 17404114
Code info: 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, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 24, 2026
  2. Published
    Apr 15, 2026
Recall number
D-0447-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.