Ge Healthcare Ireland Limited: Ge Healthcare Omnipaque (iohexol) Injection, 300 Mg/ml (64.7%)
Recall Summary GE Healthcare is recalling Omnipaque (iohexol) Injection, 300 mg/mL, a contrast dye used in medical imaging procedures, because some batches contain small particles of matter. The recall affects the product 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, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
- 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/946abf16-6b94-4cfa-9978-fddcd0b5ead1