FDA Recall D-0447-2026

GE Healthcare Ireland Limited

Class II Ongoing 51 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 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

Quantity: 866,570 vials

Reason for recall

Presence of particulate matter

Recall record

Recall number: D-0447-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: U.S. Nationwide.
Recall initiated: 2026-03-24
Classified by FDA Center: 2026-04-09
FDA published: 2026-04-15
Recalling firm: GE Healthcare Ireland Limited

Drug identification

Brand name(s): OMNIPAQUE
Generic name(s): IOHEXOL
Manufacturer(s): GE Healthcare Inc.
NDC(s): 0407-1401, 0407-1411, 0407-1412, 0407-1413, 0407-1414, 0407-1415, 0407-1416
Route(s): INTRAVASCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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