GE Healthcare Ireland Limited recalls GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlboroug…
- Recall date
- March 24, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0448-2026
- FDA classification
- Class II
- Brand / firm
- GE Healthcare Ireland Limited
- Sold / distributed
- U.S. Nationwide.
Why it was recalled
Presence of particulate matter
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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