SAHPRA recalls four batches of Enalapril 10mg Arya over specification failure

The South African Health Products Regulatory Authority (SAHPRA) has initiated the recall of four batches of Enalapril 10mg Arya, an antihypertensive, after post-marketing surveillance inspections identified out-of-specification results.

Pharmacies, wholesalers and other suppliers must identify the affected batches immediately, stop dispensing, selling and distributing them, quarantine the stock and return it through the supply chain under the instructions issued by Arya Pharma (Pty) Ltd. Three batches carry expiry dates of September 2026 and one expires this month, so a substantial proportion is likely to be in patients’ hands rather than on shelves — dispensing records for the batch numbers below are worth checking, not only warehouse stock.

Affected batches, all 28-tablet packs:

The recall is classified as Class II-Type A and is being implemented by Arya Pharma in consultation with SAHPRA under the Medicines and Related Substances Act 101 of 1965 as amended. SAHPRA said the recall is limited to the four batches listed.

Patients taking Enalapril 10mg Arya should check the batch number on their packaging, and those holding an affected batch should contact their pharmacist or healthcare professional for advice and, where necessary, request an alternative. SAHPRA states that patients should not stop taking their blood-pressure medicine without first consulting a doctor, pharmacist or other healthcare professional.

Source: “SAHPRA Recalls Certain Batches Of Enalapril 10mg Arya”, SAHPRA, Pretoria, 16 August 2026 — https://www.sahpra.org.za/sahpra-recalls-certain-batches-of-enalapril-10-mg-used-to-treat-high-blood-pressure/