GE Healthcare Omnipaque — Class II drug recall D-0447-2026
Ongoing recall by GE Healthcare Ireland Limited, reported 2026-04-15, distributed nationwide. Presence of particulate matter
| Recall number | D-0447-2026 |
|---|---|
| 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 | 866,570 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 | 17225029, 17265376, 17270885, 17292246, 17301805, 17301807, 17301810, 17304992, 17304993, 17304996, 17321225, 17333589, 17333611, 17333613, 17357000, 17366399, 17376486, 17404114 |
| Expiration dates | 2028-09-03, 2028-09-07, 2028-09-08, 2028-09-10, 2028-10-03, 2028-10-04, 2028-10-05, 2028-10-18, 2028-10-19, 2028-10-20, 2028-11-24, 2028-11-25, 2028-12-05, 2028-12-06, 2028-12-14 |
Product
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.
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-0447-2026. 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.