South Africa recalls four batches of Arya Pharma Enalapril 10 mg over failed quality tests
Arya Pharma is implementing the Class II Type A recall in consultation with Sahpra and in accordance with the Medicines and Related Substances Act 101 of 1965, as amended.
SOUTH AFRICA—Arya Pharma has recalled four batches of its Enalapril 10 mg Arya blood-pressure medicine after post-marketing surveillance inspections identified results that did not meet the required specifications.
The South African Health Products Regulatory Authority (Sahpra) initiated the recall following the inspection findings.
Arya Pharma is implementing the Class II Type A recall in consultation with Sahpra and in accordance with the Medicines and Related Substances Act 101 of 1965, as amended.
Four Enalapril batches recalled
The recall affects four batches of Enalapril 10 mg Arya, all supplied in packs of 28 tablets.
The affected products include Batch GQQ24053 (manufactured September 2024, expires August 2026) and Batches GQQ24064, GQQ24066, and GQQ24067 (all manufactured October 2024, expire September 2026).
Sahpra has advised patients taking Enalapril 10 mg Arya to check the batch number printed on their medicine packaging to determine whether their product is affected.
Patients who have medicine from any of the four recalled batches should contact their pharmacist, doctor, or other healthcare professional for advice.
Where appropriate, healthcare professionals can recommend an alternative medicine.
Patients advised not to stop treatment
Enalapril is used to manage high blood pressure, making continued treatment important for patients who rely on the medicine to control their condition.
However, Sahpra has advised patients not to stop taking their blood-pressure medication without first consulting a doctor, pharmacist or another qualified healthcare professional.
The regulator also emphasised that the recall applies only to the four identified batches of Enalapril 10 mg Arya.
Patients using other batches should therefore continue to follow their healthcare professional’s instructions unless advised otherwise.
Instructions for Medicine Suppliers
Sahpra has also instructed healthcare professionals, pharmacies, wholesalers and other medicine suppliers to immediately check their inventories for the affected batches.
Suppliers who identify recalled stock must stop dispensing, selling or distributing the affected products.
They should also quarantine the affected stock to prevent further supply and return it through the established supply chain in accordance with the recall instructions issued by Arya Pharma (Pty) Ltd.
Sahpra has urged all parties involved in the medicine supply chain to act promptly to identify and remove the affected batches from circulation.
Patients and healthcare professionals can use the batch numbers on the product packaging to distinguish the recalled medicines from other Enalapril 10 mg Arya batches.
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