MCAZ Flags Recalled Urografin Injection Over Cancer Risk Fears
The Medicines Control Authority of Zimbabwe has warned healthcare providers and the public against using Urografin 60% after tests linked the product to a genotoxic and potentially carcinogenic impurity.
In a circular dated March 19, 2026, the regulator said it had received a “critical communication” from Bayer Pty Ltd regarding a voluntary recall of all batches of Meglumine Amidotrizoate/Sodium Amidotrizoate (Urografin 60%) solution for injection manufactured between October 2020 and March 2025.
Urografin 60% is a contrast agent used in X-ray and other diagnostic imaging procedures.
According to the MCAZ, the recall follows confirmatory testing which detected an impurity, N-Nitroso-Meglumine (NO-Meglumine), at levels exceeding newly established safety thresholds.
“Recent in-vivo studies have confirmed that the impurity N-Nitroso-Meglumine is genotoxic and potentially carcinogenic,” the authority said, adding that updated scientific evidence has led to a significant reduction in the acceptable daily intake limit for the substance.
Despite the product having been registered in Zimbabwe in 2018, MCAZ said there is no record of its importation into the country between 2020 and 2026. However, the authority warned of the possibility that affected batches could have entered the market through “unauthorised or illegal channels.”
“As a precautionary measure, the Authority is therefore issuing a formal alert for this product,” the circular reads.
MCAZ has urged healthcare providers, pharmacies and the public not to use the product if encountered and to report any sightings immediately.
“In the unlikely event that members of the public encounter Urografin 60%, they are urged to immediately notify the Authority or a healthcare provider and refrain from administering it to patients,” the regulator said.
The authority said it will intensify market surveillance through inspections and public awareness campaigns to prevent circulation of the recalled medicine.
The alert comes at a time of heightened scrutiny over medicine safety and supply chain integrity, with regulators increasingly concerned about the infiltration of unregistered or recalled pharmaceutical products into local markets.
