The Medicines Control Authority of Zimbabwe (MCAZ) has advised the public about the recall of Azithromycin 500mg USP Tablets, Batch Number 24050191, manufactured by Indoco Remedies Limited in India.
MCAZ Director-General Richard Rukwata on Monday, 13 April 2026, advised healthcare professionals, licensed pharmaceutical stakeholders and the general public of a Class II recall of the medicine, extending up to the retail level.
“This recall follows a voluntary notification from the manufacturer after an out-of-specification (OOS) result was identified during dissolution testing conducted as part of a 24-month stability
study,” said Rukwata.
“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.”
He urged all licensed wholesalers, pharmacies, public and private clinics, and hospitals to quarantine any affected product units and to cooperate with Indoco Remedies Limited and its local distributors in Zimbabwe during the recall process.
Rukwata also advised members of the public who may have purchased the affected batch to return the product to the pharmacy where it was obtained.
Patients who have recently used the medicine are encouraged to consult their healthcare professionals for further guidance.
“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 Rukwata.
“MCAZ will continue to monitor the recall process and provide updates where necessary.”
Leave a Reply Cancel reply