The Pharmacy and Medicines Regulatory Authority (PMRA) has warned Malawians against the use and sale of specified batches of Nifedipine 10mg and Levodopa/Carbidopa tablets manufactured by Remedica Ltd of Cyprus.
The warning follows an official regulatory recall issued by the Medicines Control Authority of Zimbabwe (MCAZ) after out-of-specification results were confirmed during ongoing stability testing of the medicines.
According to a public safety alert dated September 15, 2026, the affected medicines include Nifedipine 10mg tablets, Levodopa/Carbidopa 100mg/25mg tablets and Levodopa/Carbidopa 250mg/25mg tablets.
The affected batches are:Nifedipine 10mg: 112033 and 117367, Levodopa/Carbidopa 100mg/25mg: 97261, 102600, 102603 and 107232, Levodopa/Carbidopa 250mg/25mg: 99671, 102751 and 102752.
PMRA says the Nifedipine batches have an out-of-specification dissolution profile, particularly affecting the early stages of dissolution.
For Levodopa/Carbidopa 100mg/25mg tablets, the defect involves a change in appearance, with the tablets changing from yellow to dark yellow or brownish towards the end of their shelf life.
The 250mg/25mg tablets were also found to have a change in appearance, from blue to yellowish green, together with recurring out-of-specification results associated with a decrease in the carbidopa assay.
PMRA says neither the Nifedipine 10mg nor Levodopa/Carbidopa tablets manufactured by Remedica Ltd are registered for use in Malawi.
The Authority has therefore not authorised any person or establishment to import, distribute, sell or supply the affected products in the country.
However, PMRA has warned that if any of the affected products are found to have been illegally imported into Malawi, they would be in violation of the Pharmacy and Medicines Regulatory Authority Act (2019), and their quality, safety and effectiveness cannot be guaranteed.
The Authority has directed all licensed pharmaceutical wholesalers, pharmacies, drug stores and healthcare facilities to immediately inspect their stocks for the affected products and batch numbers.
They have also been ordered to stop the sale, distribution and dispensing of any affected stock, if found, quarantine it and keep it clearly labelled and separated from usable medicines while awaiting further instructions from PMRA.
Any discovery of the affected stock must also be reported to PMRA without delay, including the quantity held, batch numbers and source of supply.
Members of the public have similarly been advised to check any Nifedipine or Levodopa/Carbidopa medicines in their possession against the affected product and batch numbers.
Those who have any of the affected batches have been advised to stop using the medicines immediately and return them to the pharmacy or health facility where they were obtained.
PMRA has further urged consumers to purchase medicines only from pharmacies and health facilities licensed by the Authority.
The Authority has also reminded pharmaceutical importers, retailers, healthcare workers and consumers to remain vigilant and report suspected poor-quality medicines.
The warning follows an official regulatory recall issued by the Medicines Control Authority of Zimbabwe (MCAZ) after out-of-specification results were confirmed during ongoing stability testing of the medicines.
According to a public safety alert dated September 15, 2026, the affected medicines include Nifedipine 10mg tablets, Levodopa/Carbidopa 100mg/25mg tablets and Levodopa/Carbidopa 250mg/25mg tablets.
The affected batches are:Nifedipine 10mg: 112033 and 117367, Levodopa/Carbidopa 100mg/25mg: 97261, 102600, 102603 and 107232, Levodopa/Carbidopa 250mg/25mg: 99671, 102751 and 102752.
PMRA says the Nifedipine batches have an out-of-specification dissolution profile, particularly affecting the early stages of dissolution.
For Levodopa/Carbidopa 100mg/25mg tablets, the defect involves a change in appearance, with the tablets changing from yellow to dark yellow or brownish towards the end of their shelf life.
The 250mg/25mg tablets were also found to have a change in appearance, from blue to yellowish green, together with recurring out-of-specification results associated with a decrease in the carbidopa assay.
PMRA says neither the Nifedipine 10mg nor Levodopa/Carbidopa tablets manufactured by Remedica Ltd are registered for use in Malawi.
The Authority has therefore not authorised any person or establishment to import, distribute, sell or supply the affected products in the country.
However, PMRA has warned that if any of the affected products are found to have been illegally imported into Malawi, they would be in violation of the Pharmacy and Medicines Regulatory Authority Act (2019), and their quality, safety and effectiveness cannot be guaranteed.
The Authority has directed all licensed pharmaceutical wholesalers, pharmacies, drug stores and healthcare facilities to immediately inspect their stocks for the affected products and batch numbers.
They have also been ordered to stop the sale, distribution and dispensing of any affected stock, if found, quarantine it and keep it clearly labelled and separated from usable medicines while awaiting further instructions from PMRA.
Any discovery of the affected stock must also be reported to PMRA without delay, including the quantity held, batch numbers and source of supply.
Members of the public have similarly been advised to check any Nifedipine or Levodopa/Carbidopa medicines in their possession against the affected product and batch numbers.
Those who have any of the affected batches have been advised to stop using the medicines immediately and return them to the pharmacy or health facility where they were obtained.
PMRA has further urged consumers to purchase medicines only from pharmacies and health facilities licensed by the Authority.
The Authority has also reminded pharmaceutical importers, retailers, healthcare workers and consumers to remain vigilant and report suspected poor-quality medicines.
