Rosemary Osuoha
Rosemary Osuoha

B.Pharm , MPSN

NAFDAC Issues Alert Over Substandard Contrast Injection Medicines Detected Globally

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert following a World Health Organization (WHO) notification about substandard batches of three widely used contrast injection medicines: Accupaque (iohexol), Omnipaque (iohexol), and Visipaque (iodixanol). These medicines are commonly used during CT scans, angiography, and other imaging procedures to improve the visibility of organs and blood vessels. The alert highlights concerns about product quality and patient safety across all WHO regions. Source: Public Alert No. 028/2026- Recall Of Children’s Ibuprofen Oral …

  • NAFDAC is warning healthcare providers and the public about substandard batches of Accupaque, Omnipaque, and Visipaque contrast injection medicines.
  • The alert was issued after a WHO notification involving affected products detected across multiple regions globally.
  • These medicines are used during imaging procedures such as CT scans and angiography to improve image quality.
  • Substandard medicines may affect diagnostic accuracy and potentially pose risks to patient safety.
  • Healthcare facilities are advised to verify product authenticity, batch details, and supply sources before use.
  • Patients should seek care only from licensed hospitals and diagnostic centers using approved medicines.

What Happened?

NAFDAC announced Public Alert No. 26/2026 following a WHO warning about substandard versions of Accupaque (iohexol), Omnipaque (iohexol), and Visipaque (iodixanol). The WHO alert indicated that affected products had been identified in all WHO regions, raising concerns about the quality and integrity of these contrast agents used in medical imaging. Source: Public Alert No. 028/2026- Recall Of Children’s Ibuprofen Oral …

According to the alert, the products may not meet required quality standards, which could compromise their safety, effectiveness, or reliability during diagnostic procedures. NAFDAC advised healthcare institutions, distributors, and professionals to remain vigilant and ensure that only genuine, quality-assured products are used.

Why It Matters To Your Health

Contrast agents such as iohexol and iodixanol play an important role in modern medical imaging. They help doctors obtain clearer images of organs, blood vessels, and tissues during procedures like CT scans, angiograms, and other radiological examinations.

If a contrast medicine is substandard, it may not perform as expected. This could lead to:

  • Poor image quality that affects diagnosis.
  • Repeat imaging procedures, which may expose patients to additional radiation or inconvenience.
  • Unexpected adverse reactions if the product contains impurities or does not meet safety standards.
  • Delays in diagnosis and treatment decisions.

For patients, the alert underscores the importance of receiving imaging services from licensed healthcare facilities that source medicines through approved channels. It also highlights why regulatory agencies continuously monitor medicine quality to protect public health.

What You Can Do

Patients and caregivers can take practical steps to reduce risk and ensure safer healthcare experiences:

  • Use reputable hospitals, clinics, and diagnostic centers for imaging procedures.
  • Ask healthcare providers or pharmacists if you have concerns about the medicines used during your procedure.
  • Ensure that healthcare facilities obtain medicines from licensed and authorized suppliers.
  • Report any unusual reactions or concerns after a contrast imaging procedure to a healthcare professional promptly.
  • Stay informed through official updates from NAFDAC and trusted healthcare sources.

Healthcare professionals and facilities should verify batch numbers, inspect product packaging, and report any suspected substandard products through appropriate pharmacovigilance channels.

What are contrast agents?

Contrast agents are special medicines used in imaging tests to make certain parts of the body more visible. Iohexol and iodixanol are iodine-containing contrast media commonly used in CT scans and angiography. They help radiologists obtain clearer images for diagnosing conditions involving the brain, heart, blood vessels, kidneys, and other organs.

What does “substandard” mean?

A substandard medicine is a product that fails to meet approved quality specifications. This may involve problems with composition, sterility, concentration, packaging, labeling, or manufacturing standards. Substandard products can reduce effectiveness and may increase safety risks.

Why are these medicines important?

Accupaque, Omnipaque, and Visipaque are widely used because they are effective in enhancing diagnostic images. Accurate imaging is essential for detecting diseases, guiding treatment decisions, and monitoring patient health.

What are the potential risks?

The specific risks depend on the nature of the quality defect, but possible concerns include reduced image clarity, incorrect dosing, contamination, or unexpected side effects. Patients with kidney problems, allergies to contrast media, or certain medical conditions may already require special precautions when receiving these medicines, making product quality especially important.

How are substandard medicines detected?

Regulatory agencies and manufacturers monitor medicine quality through inspections, laboratory testing, adverse event reports, and international information-sharing systems. When a potential problem is identified, alerts and recalls may be issued to prevent further use of affected products.

When To Speak With A Healthcare Professional

Speak with a pharmacist, doctor, or radiology specialist if:

  • You are scheduled for a CT scan, angiogram, or other imaging procedure and have concerns about the contrast medicine being used.
  • You have a history of kidney disease, allergies, or previous reactions to contrast agents.
  • You experience symptoms such as rash, difficulty breathing, swelling, severe nausea, or unusual reactions after a contrast-enhanced imaging procedure.
  • You are unsure whether a healthcare facility is using approved and quality-assured medicines.

Seek immediate medical attention for severe allergic reactions, breathing difficulties, chest pain, or any sudden serious symptoms after receiving a contrast injection.

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Medical Disclaimer

This content is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before starting, stopping, or changing any medication or treatment plan.

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