The Medicines Control Authority of Zimbabwe has announced the recall of a batch of Azithromycin 500mg USP tablets after laboratory testing identified quality defects that could affect the medicine’s effectiveness.
In a media release issued on April 13, 2026, the medicines regulator confirmed a Class II recall up to retail level of Azithromycin 500mg USP Tablets, Batch Number 24050191, manufactured by Indoco Remedies Limited of India.
MCAZ said the recall followed a voluntary notification from the manufacturer after an out-of-specification result emerged during stability testing.
“This recall follows a voluntary notification from the manufacturer after an out-of-specification result was identified during dissolution testing conducted as part of a 24-month stability study,” the Authority said.
According to the regulator, the identified defect means the medicine does not fully comply with approved product specifications and may fail to deliver the required therapeutic effect.
“The identified quality defect indicates non-compliance with approved product specifications, which may compromise the effectiveness of the medicine in treating bacterial infections and contribute to the development of antimicrobial resistance if therapeutic levels are not achieved,” MCAZ said.
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Health facilities and pharmaceutical distributors across Zimbabwe have been instructed to immediately isolate affected stock.
“The Authority would like to draw the attention of all licensed wholesalers, pharmacies, public and private clinics, and hospitals that they should quarantine any of the affected units of the reported product and cooperate with Indoco Remedies Limited and local distributors of the product in Zimbabwe during the recall process,” the statement read.
Members of the public who may have purchased the affected batch have been advised to return the medicine to the pharmacy where it was obtained, while patients who recently used the product should consult healthcare professionals for medical guidance.
MCAZ emphasised that the recall forms part of its ongoing mandate to protect patients and maintain confidence in medicines circulating on the local market.
“The Authority remains committed to safeguarding public health by ensuring that all medicines available in Zimbabwe meet the required standards of quality, safety, and efficacy,” said MCAZ Director-General Richard Rukwata.
The regulator added that it will continue monitoring the recall process and provide updates where necessary as part of its post-market surveillance and pharmacovigilance responsibilities.
Azithromycin is a commonly prescribed antibiotic used to treat a range of bacterial infections, making regulatory oversight critical in preventing treatment failure and limiting the spread of antimicrobial resistance.
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