Zimbabwe’s medicines regulator has ordered the recall of a batch of Azithromycin 500mg tablets after quality testing found the antibiotic failed to meet approved specifications, raising concerns about its effectiveness in treating bacterial infections.
The Medicines Control Authority of Zimbabwe (MCAZ) announced Monday that it had issued a Class II recall of Azithromycin 500mg USP Tablets, Batch Number 24050191, manufactured by India-based Indoco Remedies Limited.
The recall extends to the retail level, requiring pharmacies, clinics, hospitals and wholesalers to remove the affected batch from circulation immediately.
According to MCAZ, the recall was triggered after the manufacturer voluntarily reported an out-of-specification result during dissolution testing as part of a 24-month stability study.
Dissolution testing measures how effectively a tablet releases its active ingredient into the body.
Regulators said the defect could reduce the medicine’s therapeutic effectiveness and may contribute to antimicrobial resistance if patients do not receive sufficient levels of the drug during treatment.
“The identified quality defect indicates non-compliance with approved product specifications,” the authority said in a statement, warning that the issue may compromise treatment outcomes for bacterial infections.
MCAZ instructed all licensed pharmaceutical wholesalers, pharmacies, public and private clinics, and hospitals to quarantine any remaining stock of the affected batch and cooperate with the manufacturer and local distributors during the recall process.
Members of the public who purchased the affected medication have been advised to return it to the pharmacy where it was obtained.
Patients who have recently used the recalled batch are also being urged to consult healthcare professionals for guidance.
Azithromycin is a commonly prescribed antibiotic used to treat a range of bacterial infections, including respiratory, skin and sexually transmitted infections.
The Medicines Control Authority said it will continue monitoring the recall and provide updates if necessary, reiterating its commitment to ensuring that medicines available in Zimbabwe meet required standards of quality, safety and efficacy.
The recall comes amid growing global scrutiny of pharmaceutical quality assurance as regulators seek to prevent substandard medicines from entering supply chains and undermining public health.
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