MCAZ Recalls Three Drug Batches Over Quality Failures
By Desire Tshuma
Harare – The Medicines Control Authority of Zimbabwe has ordered the recall of specified batches of three prescription medicines after laboratory testing uncovered quality failures that could affect their performance.
MCAZ has instituted a Class II recall up to retail level for Nifedipine 10mg tablets, and Levodopa/Carbidopa 100mg/25mg and 250mg/25mg tablets. All the affected medicines were manufactured by Remedica Ltd of Limassol, Cyprus.
According to the regulator, the recall follows confirmed Out-of-Specification results detected by the manufacturer during ongoing stability testing.
Two batches of Nifedipine 10mg — 112033 and 117367 — were found to have dissolution profiles outside specifications, predominantly affecting the early stages of dissolution. MCAZ said the remaining dissolution stages were within specification.
For Levodopa/Carbidopa 100mg/25mg, the affected batches are 97261, 102600, 102603 and 107232. The tablets underwent an appearance change, with the colour shifting from yellow to dark yellow or brownish at the end of their shelf life.
Three batches of Levodopa/Carbidopa 250mg/25mg — 99671, 102751 and 102752 — were also affected. MCAZ said the tablets changed in appearance from blue to yellowish green and were linked to recurring OOS results tied to a decrease in the Carbidopa assay.
The regulator has directed all licensed pharmaceutical wholesalers, pharmacies, public and private clinics and hospitals to immediately stop distribution and sale of the affected batches, and to return any remaining stock to their suppliers.
Members of the public who may have the affected medicines have been advised to stop using the recalled batches and return them to the pharmacy or health facility where they were obtained.
MCAZ said it will continue monitoring the situation and issue further guidance where necessary.
The recall raises renewed concerns about pharmaceutical quality-control systems, particularly stability testing, which is designed to ensure medicines remain within required specifications throughout their shelf life.
The recall notice was issued by MCAZ Director-General Richard T. Rukwata on 11 September 2026.
