Drug recall D-0447-2026
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
Lots and codes
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
Recall details
- Recalling firm
- GE Healthcare Ireland Limited, Carrigtwohill
- Quantity
- 866,570 vials
- Distribution
- U.S. Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 24, 2026
Related products
- Omnipaque – drug information
- NDC 0407-1411 Omnipaque · Iohexol 180 mg/mL · GE Healthcare Inc.
- NDC 0407-1415 Omnipaque · Iohexol 9 mg/mL · GE Healthcare Inc.
- NDC 0407-1401 Omnipaque · Iohexol 140 mg/mL · GE Healthcare Inc.
- NDC 0407-1413 Omnipaque · Iohexol 300 mg/mL · GE Healthcare Inc.
- NDC 0407-1412 Omnipaque · Iohexol 240 mg/mL · GE Healthcare Inc.
- NDC 0407-1414 Omnipaque · Iohexol 350 mg/mL · GE Healthcare Inc.
- NDC 0407-1416 Omnipaque · Iohexol 12 mg/mL · GE Healthcare Inc.