Online Reporter
Rutendo Nyeve [email protected]
THE Medicines Control Authority of Zimbabwe (MCAZ) has issued a urgent Class II recall for specific batches of three widely used medications manufactured by Remedica Ltd, based in Limassol, Cyprus.
The recall, announced in a Circular No. 22 of 2026, affects Nifedipine 10mg tablets and two variations of Levodopa/Carbidopa tablets, following confirmed Out-of-Specification (OOS) results.
In a statement accompanying the circular, MCAZ Director-General, Mr Richard Rukwata, emphasised the severity of the situation.
“Reference is made to confirmed Out-Of-Specification results identified by the manufacturer during ongoing stability testing,” Mr Rukwata said.
“In light of the confirmed results, the Authority hereby institutes a Class II recall up to retail level of the above batches.”
Mr Rukwata directed all licensed pharmaceutical wholesalers, pharmacies, public and private clinics, and hospitals to immediately cease further distribution and sale of the affected batches and to return any stock in their possession to the supplier.
Nifedipine 10mg tablets are a very common calcium channel blocker prescribed to manage high blood pressure and angina among thousands of Zimbabweans living with hypertension,
The affected batches, specifically batch numbers 112033 and 117367, have been flagged for a dissolution-profile OOS.
This means the medication does not dissolve properly in the body, predominantly affecting the early stages of dissolution.
Consequently, the drug may not release its active ingredient into the bloodstream as intended, potentially compromising its effectiveness in lowering blood pressure.
The recall extends beyond hypertension medication to include treatments for Parkinson’s disease and other neurological conditions.
The affected Levodopa/Carbidopa 100mg/25mg tablets (batches 97261, 102600, 102603, and 107232) were found to undergo an appearance change, turning from yellow to a dark yellow or brownish hue by the end of their shelf life. While appearance changes are physical, they indicate potential chemical instability.
More critically, the Levodopa/Carbidopa 250mg/25mg tablets (batches 99671, 102751, and 102752) were found to have a drastic appearance change from blue to yellowish-green.
In addition to the physical discoloration, these batches exhibited recurring OOS results associated with a decrease in Carbidopa assay.
This means the actual amount of the active ingredient in the tablet is lower than required, which could lead to a return of Parkinson’s symptoms in patients relying on this medication.
The MCAZ has also issued a direct appeal to the public.
“Members of the public who may be in possession of these specific batches are advised to stop using them immediately and return them to the pharmacy or health facility from which they were obtained,” MCAZ said.
The Authority assured the nation that it will continue to monitor the situation and will communicate further guidance as necessary. Patients currently on these medications are urged to consult their healthcare providers for alternative treatment options.
