The Health Department has sought to allay concerns about the use of Enalapril medication following a recent recall of the product.  

Earlier this month, the South African Health Products Regulatory Authority (SAHPRA) initiated the recall of four batches of the product’s 10 mg variant by Arya Pharma, following “the identification of out-of-specification results during post-marketing surveillance inspections”.

The department advised that public health facilities dispensing the medication, used for high blood pressure and the management of heart failure, currently supply the Enalapril 5 mg variant.

It clarified that the recall applies specifically to certain batches of the 10 mg variant supplied by Arya Pharma. 

He said the 10 mg tablets had been approved as a temporary alternative while the contracted supplier, Austell Pharmaceuticals, experienced a delay in releasing its Enalapril 5 mg product following quality checks by SAHPRA. 

Department spokesperson Foster Mohale said patients using Enalapril 5 mg can continue taking the medication as prescribed. 

“The Department of Health wishes to reassure patients, healthcare professionals and the general public that the recent recall of Enalapril 10 mg tablets does not affect the same product packaged at 5 mg which is currently being supplied to public sector health facilities,” Mohale said. 

Mohale said the department had confirmed with SAHPRA that Enalapril Arya 5 mg tablets can be used and distributed, and that all batches supplied to the public health sector meet the required quality and registration standards. 

“Patients using Enalapril 5 mg tablets do not need to stop taking this life-saving medicine mainly because of the recall of the 10 mg tablets,” he said. 

The department has also advised healthcare professionals to continue prescribing and dispensing Enalapril 5 mg in line with existing clinical protocols. 

It has requested provinces and healthcare facilities to share the information with healthcare professionals and other relevant stakeholders to prevent unnecessary concern or disruption to patients.