Zimbabwe recalls Urografin imaging agent due to cancer-risk impurity

ZIMBABWE—The Medicines Control Authority of Zimbabwe (MCAZ) has issued a public alert warning about the recall of Urografin 60%, a contrast solution used in X-ray and diagnostic imaging procedures.

The alert follows a voluntary recall initiated by Bayer Pty Ltd of South Africa, which flagged specific batches of the injectable product, Meglumine Amidotrizoate/Sodium Amidotrizoate 0.3/0.6/0.76 g/ml Solution for Injection, due to serious safety concerns.

The recall covers all batches of Urografin 60% manufactured between October 2020 and March 2025.

Confirmatory laboratory testing revealed the presence of a chemical impurity, N-Nitroso-Meglumine (NO-Meglumine), in the product at levels exceeding newly established safety thresholds.

Recent animal studies have since confirmed that this impurity is genotoxic and is potentially carcinogenic.

In response to this scientific evidence, regulators have significantly lowered the acceptable daily intake limit for the impurity to protect patients better.

Although MCAZ registered Urografin 60% in Zimbabwe back in 2018, the authority says its importation records show no evidence of the product entering the country through official channels between 2020 and 2026.

However, the authority has not ruled out the possibility that affected batches may have reached the local market through unauthorised or illegal supply routes.

Out of caution, MCAZ issued this formal alert to address any potential public health risk.

The public has been advised that if they come across Urografin 60%, MCAZ has them not to administer it to patients under any circumstances.

Instead, they should immediately report the find to MCAZ or the nearest healthcare provider.

The authority is also stepping up market surveillance by increasing facility inspections and public awareness campaigns to prevent the product from circulating in Zimbabwe’s healthcare system.