Iohexol Recall: Omnipaque Injection 350 mg/mL
Announced 2026-04-15 · FDA
GE Healthcare Ireland Limited is recalling Omnipaque (iohexol) Injection, 350 mg/mL, Rx Only, distributed in the U.S. by GE Healthcare Inc., due to the presence of particulate matter. The recall involves 866,570 vials across multiple lots with expiration dates through 2028. No corrective action is specified in the notice.
| Brand | GE Healthcare Ireland Limited |
|---|---|
| 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 |
| Severity | moderate |
| Units affected | 306810 |
| Distribution | U.S. Nationwide. |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Do not use any Omnipaque iohexol Injection from recalled lots.
- Check your vials for the listed lot numbers and segregate affected products.
- Contact the facility or supplier to arrange replacement or return.
- If you have concerns or have experienced symptoms, contact your healthcare provider and report to the FDA.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.