CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL 7%) recalled
GE Healthcare Ireland is recalling GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL 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-0447-2026
- FDA event ID
- 98656
- Recalling firm
- GE Healthcare Ireland, 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, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Is GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL 7%) recalled?
Yes. GE Healthcare Ireland recalled GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL 7%) on 24 Mar 2026. The recall is Class II and its status is Ongoing. Recall number D-0447-2026.
Why was it recalled?
Presence of particulate matter
Which lots are affected?
Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE Healthcare Ireland
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL 7%) recalledOmnipaque | GE Healthcare Ireland | Particulate Matter | Nationwide |
Other Iohexol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL 7%) recalledOmnipaque | GE Healthcare Ireland | Particulate Matter | Nationwide |
| Drug | CLASS II | Omnipaque (iohexol) Injection, 180mgI/mL Single-Dose Vial recalledOmnipaque | GE Healthcare Inc. Life Sciences | Particulate Matter | TN |