MCAZ Recalls Nifedipine and Levodopa/Carbidopa Batches Over Quality Concerns

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 Ltd in Cyprus after out-of-specification (OOS) quality results were confirmed on 7 September  2026.

The recall affects licensed pharmacies, wholesalers, public and private clinics, hospitals and consumers across Zimbabwe. MCAZ said the affected medicines must be withdrawn from sale and distribution and returned to suppliers.

The authority issued Circular No. 22 of 2026 following OOS results identified by the manufacturer during ongoing stability testing of the medicines.

The affected Nifedipine 10mg tablets are batches 112033 and 117367. MCAZ said the quality problem involved the dissolution profile, mainly affecting the early stages of dissolution, although the remaining dissolution stages were within specification.

The recall also affects Levodopa/Carbidopa 100mg/25mg tablets from batches 97261, 102600, 102603 and 107232.

According to MCAZ, an appearance change was observed in these tablets, with their colour changing from yellow to dark yellow or brownish towards the end of their shelf life.

Three batches of Levodopa/Carbidopa 250mg/25mg tablets, namely 99671, 102751 and 102752, have also been recalled.

MCAZ reported that the tablets showed an appearance change from blue to yellowish green. Recurring OOS results were also identified and were associated with a decrease in the Carbidopa assay.

The medicines were manufactured by Remedica Ltd, Remedica Ahannon Street, Limassol, Industrial Estate, Limassol, Cyprus.

MCAZ directed all licensed pharmaceutical wholesalers, pharmacies, public and private clinics and hospitals to immediately stop further distribution and sale of the affected batches and return any stock in their possession to the supplier.

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

The authority said it would continue monitoring the situation and provide further guidance if necessary.

The recall is intended to prevent continued use or distribution of medicines whose quality has been found to fall outside specified standards.