Health department clarifies which Enalapril tablets are safe amid recall

The department of health has reassured patients and healthcare professionals that the recall of Enalapril 10mg tablets — medication used to treat high blood pressure and manage heart failure — does not affect the same product packaged at 5mg.

The lower-dosage tablet is currently being supplied to public-sector health facilities.

The August 16 recall of four batches of Enalapril 10mg tablets by the South African Health Products Regulatory Authority (Sahpra) applies specifically to those supplied by Arya Pharma.

In its announcement, the authority said the recall followed the identification of out-of-specification results during post-marketing surveillance inspections.

The health department said the affected tablets were approved as only a temporary alternative while the contracted supplier, Austell Pharmaceuticals, experienced a delay in releasing its Enalapril 5mg product following quality checks by Sahpra.

“The department has confirmed with Sahpra that the Enalapril Arya 5mg tablets may be used and distributed in the country, and all batches supplied to the public health sector have been confirmed to meet the required quality and registration standards.

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

Healthcare professionals can also continue prescribing and dispensing Enalapril 5mg tablets in line with existing clinical protocols.