Multi-event March 2026 FDA Recall Omnipaque by Ge Healthcare Ireland Limited
This Multi-event Class II drug recall was voluntarily initiated by Ge Healthcare Ireland Limited on March 24, 2026 for the product Omnipaque. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0448-2026
Presence of particulate matter
03-24-2026
04-15-2026
306,810 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
GE Healthcare Ireland Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
Recall Number: D-0447-2026
Presence of particulate matter
03-24-2026
04-15-2026
866,570 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
GE Healthcare Ireland Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
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
