Health department says Enalapril 5mg safe after recall of 10mg batches

The Department of Health has reassured patients that Enalapril 5 mg tablets remain safe and should be continued, after the South African Health Products Regulatory Authority (SAHPRA) ordered a recall of certain batches of Enalapril 10 mg Arya.

What the department said

Health department spokesperson Foster Mohale said the recall did not extend to the 5 mg formulation supplied to public sector health facilities. He said the department had confirmed with SAHPRA that the Enalapril Arya 5 mg tablets in the public sector “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.”

Why the 10 mg tablets were recalled

The recall announced by SAHPRA affected certain batches of Enalapril 10 mg tablets manufactured by Arya Pharma. Mohale said those 10 mg tablets had been approved only 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.

Advice to patients and health facilities

Mohale urged patients “not to panic or stop their medication” and told patients using Enalapril 5 mg that they “do not need to stop taking this life-saving medicine mainly because of the recall of the 10 mg tablets.” He added that patients should keep taking their medicine as prescribed unless told otherwise by a healthcare professional.

Mohale also called on provinces and facilities to share the information with staff “to avoid unnecessary concern or disruption to patients.”

Context

The department said the Enalapril 10 mg Arya stock had been used as a short-term substitute while the usual supplier addressed production issues.

Published: 28 August 2026, 09:40