Antony Chawagarira
The Medicines Control Authority of Zimbabwe (MCAZ) has ordered a Class II recall up to retail level of specified batches of Nifedipine 10mg and Levodopa/Carbidopa tablets manufactured by Remedica Limited of Limassol, Cyprus, after the products were found to have quality concerns during ongoing stability testing.
The recall, contained in MCAZ Circular No. 22 of 2026 dated September 7, affects medicines used in the management of hypertension and Parkinson’s disease and Parkinsonism, raising the need for patients and health facilities to check their stocks against the affected batch numbers.
According to the MCAZ, the affected Nifedipine 10mg tablets are batches 112033 and 117367, which recorded out-of-specification dissolution profiles, predominantly affecting the early stages of dissolution.
“Nifedipine 10mg tablets” are commonly used in the management of high blood pressure and other cardiovascular conditions.
The authority also recalled four batches of Levodopa/Carbidopa 100mg/25mg tablets, namely 97261, 102600, 102603 and 107232.
MCAZ said an appearance change was observed in these tablets, which changed from yellow to dark yellow or brownish at the end of their shelf life.
Three batches of Levodopa/Carbidopa 250mg/25mg tablets, namely 99671, 102751 and 102752, were also affected.
“An appearance change was observed from blue to yellowish green,” MCAZ said, adding that recurring out-of-specification results associated with a decrease in the Carbidopa assay had also been identified.
Levodopa/Carbidopa is primarily used to manage symptoms associated with Parkinson’s disease and Parkinsonism, while Nifedipine is principally used to treat hypertension and other conditions requiring control of blood pressure.
MCAZ said the quality issues were confirmed by the manufacturer, Remedica Limited, during ongoing stability testing of the affected products.
“In light of the confirmed results, the Authority hereby institutes a Class II recall up to retail level of the above batches,” MCAZ said.
All licensed pharmaceutical wholesalers, pharmacies, public and private clinics and hospitals have consequently been directed to immediately stop the further distribution and sale of the affected batches and return any stock in their possession to suppliers.
Members of the public who may have any of the affected medicines have also been advised to stop using them and return them to the pharmacy or health facility from which they obtained the medicines.
“Members of the public who may be in possession of the affected products are advised to stop using them and to return them to the pharmacy or health facility from which they were obtained,” MCAZ said.
The authority said it would continue monitoring the situation and communicate further guidance as necessary.
Patients who are taking either of the recalled medicines should not simply stop essential treatment without medical advice, but should contact their pharmacist, doctor or health facility to establish whether their medicine is from one of the affected batches and, where necessary, obtain an appropriate replacement.
