GE Healthcare Omnipaque — Class II drug recall D-0448-2026

Ongoing recall by GE Healthcare Ireland Limited, reported 2026-04-15, distributed nationwide. Presence of particulate matter

Recall number	`D-0448-2026`
Product type	Drug
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	GE Healthcare Ireland Limited, Carrigtwohill, Ireland
Recall initiated	2026-03-24
Classified	2026-04-09
Reported by FDA	2026-04-15
Distributed	Nationwide (US)
Quantity	306,810 vials
Reason classes	specification failure
NDC	`00407-1401`, `00407-1401-52`, `00407-1411`, `00407-1411-10`, `00407-1411-20`, `00407-1412`, `00407-1412-10`, `00407-1412-20`, `00407-1412-27`, `00407-1412-28`, `00407-1412-29`, `00407-1412-30`, `00407-1412-33`, `00407-1412-34`, `00407-1412-35`, `00407-1412-49`, `00407-1412-50`, `00407-1412-60`, `00407-1413`, `00407-1413-10`, `00407-1413-11`, `00407-1413-30`, `00407-1413-50`, `00407-1413-51`, `00407-1413-53` and 41 more
Lot numbers	`17333197`, `17333198`, `17396945`, `17396948`, `17396953`, `17396956`, `17423503`, `17423525`, `17426429`, `17426440`, `17431310`
Expiration dates	`2028-11-17`, `2028-12-10`, `2028-12-18`, `2028-12-22`, `2029-01-01`, `2029-01-03`, `2029-01-04`, `2029-01-09`, `2029-01-11`

Product

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.

Reason for recall

Presence of particulate matter

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0448-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.