MCAZ Issues Public Alert on Urografin 60% Recall

The Medicines Control Authority of Zimbabwe (MCAZ) has issued a public warning to healthcare professionals, pharmaceutical distributors, and the general public regarding the recall of the diagnostic imaging agent Urografin 60%.

In a statement dated 19 March 2026, signed by Director-General Richard Rukwata, MCAZ confirmed it had received a notification from Bayer Pty Ltd in South Africa about a voluntary recall of certain batches of Meglumine Amidotrizoate/Sodium Amidotrizoate 0.3/0.6/0.76 g/ml solution for injection, commonly sold under the brand name Urografin 60%. The contrast medium is extensively used in X-ray and other diagnostic imaging procedures.

The recall concerns all batches produced between October 2020 and March 2025, following testing that detected N-Nitroso-Meglumine (NO-Meglumine) at levels above newly established safety limits. Studies indicate the impurity is genotoxic and potentially carcinogenic, prompting international health authorities to lower acceptable daily intake thresholds for the substance.

Although Urografin 60% was registered for use in Zimbabwe in 2018, MCAZ stated that there is no record of the product being officially imported into the country between 2020 and 2026. However, authorities cautioned that some batches could have entered the local market through unauthorized or illegal channels.

“As a precaution, the Authority is issuing a formal public alert,” the statement read.

MCAZ urged healthcare providers and the public to remain vigilant. Any encountered stock should not be administered and should instead be reported immediately to MCAZ or a qualified healthcare professional.

The Authority highlighted its commitment to ensuring the safety and quality of medicines in Zimbabwe, announcing plans to increase market inspections and awareness campaigns to prevent circulation of the recalled product.

MCAZ reaffirmed its role in protecting public health and maintaining strict standards for all medical products available in the country.