Substandard Medical Product Alert N°1/2026
ACCUPAQUE (iohexol), OMNIPAQUE (iohexol) and VISIPAQUE (iodixanol) solutions for injection in 100 ml polypropylene containers: substandard product alert
WHO issued this alert after the Health Products Regulatory Authority of Ireland notified WHO in March 2026 of a Class I quality defect. Metallic particulate matter was found adhered to or embedded in the inner surface of polypropylene bottles, and in at least one confirmed case free particulate was found in the finished product. The products were distributed mainly to hospitals.1
- Issued
- 7 May 2026
- Issued by
- World Health Organization
- Name stated on packaging
- GE HealthCare Ireland Limited, the manufacturer named in the alert. The products are genuine, not falsified.
- Genuine manufacturer's statement
- WHO said the manufacturer provided the list of affected products and batches and identified the contamination.
- Countries where detected
- Supplied globally to multiple countries, no specific countries named
Batches named in the alert
Affected batches are listed in Annexes 1 and 2 to the alert. Batches in glass containers are not affected.
Advice as stated
Identify and remove affected batches from clinical use. Make sure visual inspection is done before use. Report suspected defects or adverse events to the national regulator.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°1/2026: Substandard ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol) (7 May 2026)