Patients who are currently taking Enalapril 10mg Arya are urged to check the batch number on their medicine.
The South African Health Products Regulatory Authority (SAHPRA) has ordered the recall of four batches of Enalapril 10 mg Arya. Picture: Arya Pharma (Pty) Ltd
The South African Health Products Regulatory Authority (Sahpra) has ordered the recall of four batches of Enalapril 10mg Arya, a widely used hypertension medicine.
The recall follows post‑marketing inspections that flagged out‑of‑specification results, prompting urgent action to protect patients and safeguard public health.
Recall
Sahpra said the recall is classified as a Class II-Type A recall and is being implemented by Arya Pharma (Pty) Ltd in consultation with Sahpra in accordance with the Medicines and Related Substances Act 101 of 1965 as amended.
“The recall is limited to the specific batches listed below. Sahpra urges patients, healthcare professionals, pharmacies, wholesalers and other medicine suppliers to immediately check their stock, identify any affected batches and take the necessary action in line with the recall,” the regulator’s spokesperson, Rodgers Baloyi, said.
Enalapril
Enalapril is used to manage high blood pressure. Patients who are currently taking Enalapril 10mg Arya are urged to check the batch number on their medicine packaging to determine whether their medicine is affected.
Baloyi said patients who have one of the affected batches should contact their pharmacist or healthcare professional for advice and, where necessary, request an alternative medicine.
“Patients should not stop taking their blood-pressure medicine without first consulting their doctor, pharmacist or other healthcare professional. Sahpra emphasises that the recall concerns only the four batches.”
Action required from healthcare professionals and medicine suppliers:
Healthcare professionals, pharmacies, wholesalers and other medicine suppliers are requested to:
- Immediately identify stock from the affected batches.
- Stop dispensing, selling or distributing the affected batches.
- Quarantine affected stock.
- Return affected stock through the established supply chain in accordance with the recall instructions issued by Arya Pharma (Pty) Ltd.
Monitoring
Baloyi said Sahpra will continue to monitor the recall and take appropriate regulatory action to protect public health.
