FDA Recall D-0448-2026

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, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Lot / code: Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029

Quantity: 306,810 vials

Reason for recall

Presence of particulate matter

Recall record

Recall number: D-0448-2026
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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