GE Healthcare Omnipaque (iohexol) Injection recall
FDA recall D-0448-2026 · initiated Mar 24, 2026
GE Healthcare Ireland Limited recalled GE Healthcare Omnipaque (iohexol) Injection in Mar 2026 — an FDA Class II recall (D-0448-2026) because Presence of particulate matter.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 306,810 vials
Details
- 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.
- Recalling company
- GE Healthcare Ireland Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Mar 24, 2026
- FDA report date
- Apr 15, 2026
This recall is linked to a product we cover: Omnipaque 9 →
Frequently asked
- Was GE Healthcare Omnipaque (iohexol) Injection recalled?
- GE Healthcare Ireland Limited recalled GE Healthcare Omnipaque (iohexol) Injection in Mar 2026 — an FDA Class II recall (D-0448-2026) because Presence of particulate matter. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was GE Healthcare Omnipaque (iohexol) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0448-2026 was: Presence of particulate matter
- Is a recalled GE Healthcare Omnipaque (iohexol) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of GE Healthcare Omnipaque (iohexol) Injection are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — 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. Jan…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0448-2026.