The South African Health Products Regulatory Authority (SAHPRA) has recalled four batches of Enalapril 10mg Arya after tests raised concerns about the potency of the medication.
The recall affects specific batches manufactured in September and October 2024, which SAHPRA says may contain less of the active ingredient than required, potentially making the medication less effective.
SAHPRA spokesperson Rodgers Baloyi said the issue was identified during inspections and subsequent testing of the product.
“Our inspectors were in the field. They found out that the product did not meet the milligrams that it was required to meet for it to be effective,” Baloyi said.
Enalapril is commonly prescribed to treat high blood pressure and heart failure.
However, the Department of Health has stressed that the recall does not affect all patients taking Enalapril.
According to department spokesperson Foster Mohale, the recall specifically applies to the 10mg Enalapril tablets supplied by Arya Pharma.
The 10mg tablets had been approved as a temporary alternative while Austell Pharmaceuticals, the contracted supplier, dealt with delays in releasing its Enalapril 5mg product following SAHPRA quality checks.
The department says patients currently taking Enalapril 5mg supplied to public-sector health facilities do not need to stop taking their medication as a result of the recall.
“Patients should continue taking their medicine as prescribed unless advised otherwise by their healthcare professionals,” Mohale said.
Healthcare professionals have also been advised to continue prescribing and dispensing Enalapril 5mg in accordance with existing clinical protocols.
Patients who are unsure whether their medication is part of the recalled batches are encouraged to speak to their doctor or pharmacist rather than stopping treatment on their own.