South Africa’s South African Health Products Regulatory Authority (SAHPRA) has initiated the recall of four batches of Enalapril 10mg Arya, a medicine commonly used to manage high blood pressure.
The recall follows the identification of out-of-specification results during post-marketing surveillance. SAHPRA classifies the action as a Class II Type A recall.
The recall is being implemented by Arya Pharma (Pty) Ltd in consultation with SAHPRA under South Africa’s Medicines and Related Substances Act 101 of 1965, as amended.
Four Batches Affected
SAHPRA has identified the affected batches as:
- GQQ24053 — 28-tablet pack, expires August 2026
- GQQ24064 — 28-tablet pack, expires September 2026
- GQQ24066 — 28-tablet pack, expires September 2026
- GQQ24067 — 28-tablet pack, expires September 2026
The regulator has stressed that the recall applies only to these four identified batches.
Patients Asked to Check Their Medication
Patients currently taking Enalapril 10mg Arya have been advised to check the batch or lot number printed on their medicine packaging.
Anyone who discovers that they have one of the affected batches should contact a pharmacist or healthcare professional for advice and, where necessary, obtain an alternative medicine.
Importantly, SAHPRA has advised patients not to stop taking their blood-pressure medication without first consulting a doctor, pharmacist or other qualified healthcare professional.
Pharmacies and Suppliers Told to Act
Healthcare professionals, pharmacies, wholesalers and other medicine suppliers have also been instructed to immediately identify stock from the affected batches.
They are required to:
- Stop dispensing, selling or distributing the affected batches.
- Quarantine affected stock.
- Return the affected products through the established supply chain.
- Follow the recall instructions issued by Arya Pharma.
SAHPRA said it will continue monitoring the recall and take appropriate regulatory action where necessary to protect public health.
Why the Recall Matters
Enalapril belongs to a class of medicines used in the management of hypertension, a major risk factor for cardiovascular disease and other serious health complications.
The recall highlights the importance of post-market surveillance in identifying quality issues after medicines have reached the market.
For patients, however, the key message is to check the batch number rather than discontinue treatment on their own.
The latest recall information is also listed on SAHPRA’s official product-recall database.
