Zimbabwe Recalls BP, Parkingson's Disease Medicine Batches Over Quality Concerns

Harare — The Medicines Control Authority of Zimbabwe has instituted a Class II recall up to retail level of specific batches of Nifedipine 10mg tablets and Levodopa/Carbidopa tablets manufactured by Remedica Ltd of Limassol, Cyprus.  

The recall follows Circular No. 22 of 2026, dated September 2026.

The authority made reference to confirmed Out-Of-Specification (OOS) results identified by the manufacturer during ongoing stability testing of the products.

The test results did not meet the required quality standards set for the medicines.  

Nifedipine is a medicine commonly used to treat high blood pressure, also known as hypertension, and angina, which is a type of chest pain.

It works by relaxing and widening blood vessels so blood can flow more easily.  

Levodopa/Carbidopa on the other hand, is used to treat the symptoms of Parkinson’s disease.

The affected products and issues have been listed as are as Nifedipine 10mg tablets, batches 112033 and 117367 which showed a dissolution-profile OOS.

Dissolution-profile refers to how the tablet dissolves to release the active medicine into the body.

The problem mainly affected the early stages of dissolution, while later stages remained within specification.  

For Levodopa/Carbidopa 100mg/25mg tablets, batches 97261, 102600, 102603 and 107232 showed an appearance change.

The tablets changed from yellow to dark yellow or brownish towards the end of their shelf life.  

For Levodopa/Carbidopa 250mg/25mg tablets, batches 99671, 102751 and 102752, they showed an appearance change from blue to yellowish green.

MCAZ said in addition, recurring OOS results linked to a decrease in Carbidopa assay were identified, the measured amount of the active ingredient in the tablet.  

"In light of the confirmed results, the Authority hereby institutes a Class II recall up to retail level of the above batches.

"All licensed pharmaceutical wholesalers, pharmacies, public and private clinics and hospitals are directed to immediately cease further distribution and sale of the affected batches and to return any stock in their possession to the supplier," the authority said.

A Class II recall means the product defects could cause temporary or medically reversible health problems, or the chance of serious harm is remote.  

Members of the public who may be in possession of the affected products have been advised to stop using them and to return them to the pharmacy or health facility from which they were obtained.  

“The Authority shall continue to monitor the situation and will communicate further guidance as necessary," MCAZ said.