CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%) recalled
GE Healthcare Irel is recalling GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0448-2026
- FDA event ID
- 98656
- Recalling firm
- GE Healthcare Irel, Carrigtwohill
- Brand
- Omnipaque
- Manufacturer
- GE Healthcare Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2026
- FDA classified
- 9 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Mar 2026 | Recall initiated by company | |
| 9 Apr 2026 | Classified by FDA | +16 days |
| 15 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Presence of particulate matter
Which lots are affected?
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
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%) recalledOmnipaque | GE Healthcare Irel | Particulate Matter | Nationwide |
More recalls from GE Healthcare Irel
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%) recalledOmnipaque | GE Healthcare Irel | Particulate Matter | Nationwide |
Other Iohexol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%) recalledOmnipaque | GE Healthcare Irel | Particulate Matter | Nationwide |
| Drug | CLASS II | Omnipaque (iohexol) Injection, 180mgI/mL Single-Dose Vial recalledOmnipaque | GE Healthcare Inc. Life Sciences | Particulate Matter | TN |