Zimbabwe Issues Immediate Recall Of Antibiotic Azithromycin Tablets
Zimbabwe’s medicines regulator has issued an urgent recall of antibiotic Azithromycin 500mg tablets after a quality defect was detected, raising concerns that the medication may not effectively treat bacterial infections.
The Medicines Control Authority of Zimbabwe (MCAZ) announced on 13 April 2026 that Azithromycin 500mg USP Tablets, Batch Number 24050191, manufactured by Indoco Remedies Limited in India, are being recalled up to the retail level following a failed quality assessment.
Authorities warned that the defect may compromise the antibiotic’s effectiveness and could contribute to antimicrobial resistance if patients fail to receive the required therapeutic dose.
Recall Triggered By Failed Stability Testing
In a media release dated 13 April 2026, MCAZ confirmed that the recall followed a voluntary notification from the manufacturer after an out-of-specification result was identified during routine testing.
The Authority explained:
“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.”
MCAZ said the results showed the product did not meet approved specifications.
“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.”
Azithromycin is a commonly prescribed antibiotic used to treat bacterial infections, including respiratory infections, skin infections, ear infections, and certain sexually transmitted infections.
The Authority said the recall applies specifically to Batch Number 24050191.
Pharmacies And Patients Urged To Take Immediate Action
MCAZ urged wholesalers, pharmacies, hospitals, and clinics to isolate the affected stock and cooperate with the recall process.
The Authority stated:
“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.”
Members of the public who may have purchased the antibiotic have also been advised to return it to the point of purchase.
“The general public who might have purchased the same reported batch are advised to return the product to the pharmacy where they obtained the medicine.”
Patients who recently used the medication were also encouraged to consult healthcare professionals.
“Patients who recently used this product are advised to see their healthcare professionals for assistance.”
MCAZ Says Public Health Remains Priority
MCAZ said it remains committed to ensuring medicines in Zimbabwe meet safety and quality standards.
“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. MCAZ will continue to monitor the recall process and provide updates where necessary.”
The medicines regulator also confirmed that the recall follows established regulatory procedures to protect patients and maintain medicine quality standards.
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