FDA Drugs recall ·
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only… recall
- Recall number
- D-0448-2026
- Date
- (initiated March 24, 2026)
- Company / brand
- GE Healthcare Ireland Limited
Ida Business Park, Carrigtwohill, Ireland - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 306,810 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of particulate matter
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0448-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.