FDA Drug recall D-0447-2026
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC… by Ge Healthcare Ireland, citing presence of particulate matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0447-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-24 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ge Healthcare Ireland |
| Distribution | US |
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
Presence of particulate matter
Identifiers
| ndc | 0407-1401-52 |
|---|---|
| ndc | 0407-1411-10 |
| ndc | 0407-1411-20 |
| ndc | 0407-1412-10 |
| ndc | 0407-1412-20 |
| ndc | 0407-1412-50 |
| ndc | 0407-1412-29 |
| ndc | 0407-1412-30 |
| ndc | 0407-1412-60 |
| ndc | 0407-1412-33 |
| ndc | 0407-1412-27 |
| ndc | 0407-1412-49 |
| ndc | 0407-1412-34 |
| ndc | 0407-1412-28 |
| ndc | 0407-1412-35 |
| ndc | 0407-1413-11 |
| ndc | 0407-1413-10 |
| ndc | 0407-1413-59 |
| ndc | 0407-1413-30 |
| ndc | 0407-1413-50 |
| ndc | 0407-1413-51 |
| ndc | 0407-1413-61 |
| ndc | 0407-1413-95 |
| ndc | 0407-1413-98 |
| ndc | 0407-1413-62 |
| ndc | 0407-1413-99 |
| ndc | 0407-1413-60 |
| ndc | 0407-1413-63 |
| ndc | 0407-1413-91 |
| ndc | 0407-1413-53 |
| ndc | 0407-1413-90 |
| ndc | 0407-1413-65 |
| ndc | 0407-1413-92 |
| ndc | 0407-1413-66 |
| ndc | 0407-1413-93 |
| ndc | 0407-1413-96 |
| ndc | 0407-1413-69 |
| ndc | 0407-1414-21 |
| ndc | 0407-1414-50 |
| ndc | 0407-1414-51 |
| ndc | 0407-1414-52 |
| ndc | 0407-1414-89 |
| ndc | 0407-1414-20 |
| ndc | 0407-1414-90 |
| ndc | 0407-1414-22 |
| ndc | 0407-1414-53 |
| ndc | 0407-1414-60 |
| ndc | 0407-1414-91 |
| ndc | 0407-1414-76 |
| ndc | 0407-1414-03 |
| ndc | 0407-1414-23 |
| ndc | 0407-1414-93 |
| ndc | 0407-1414-04 |
| ndc | 0407-1414-94 |
| ndc | 0407-1414-24 |
| ndc | 0407-1414-80 |
| ndc | 0407-1414-95 |
| ndc | 0407-1415-09 |
| ndc | 0407-1416-12 |
| code_info | Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 1…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0447-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.