Ge Healthcare Ireland Limited: Ge Healthcare Omnipaque (iohexol) Injection, 350 Mg/ml (64.7%)
GE Healthcare is recalling Omnipaque (iohexol) Injection 350 mg/mL, a contrast dye used in medical imaging, because it contains particulate matter (small particles). The recall affects batches distributed nationwide across all U.S. states. This is a Class II recall, meaning the product could cause adverse health effects but is unlikely to cause serious injury.
- Recalling firm
- GE Healthcare Ireland Limited
- 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.
- Reason
- Presence of particulate matter
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/c6023027-3ef0-4b0d-8fbe-c3d11c56b753