THE South African Health Products Regulatory Authority (Sahpra) has ordered a recall for four specific batches of Arya Enalapril 10mg. The medication is commonly used to manage high blood pressure.

The decision came after inspections during post-marketing surveillance revealed that some results from these batches did not meet the required specifications.

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This recall has been categorised as a Class II-Type A, meaning it’s considered a situation where use or exposure could cause temporary or medically reversible adverse health consequences. Arya Pharma (Pty) Ltd is managing the recall process, working closely with Sahpra, and following the guidelines set out in the Medicines and Related Substances Act 101 of 1965. 

Affected batches

The specific batches subject to recall are 

• Batch GQQ24053, which contains 28 tablets, was manufactured in September 2024 and is set to expire this month (August).
• Batch GQQ24064, containing 28 tablets, was manufactured in October 2024 and is set to expire in September.
• Batch GQQ24066, containing 28 tablets, was manufactured in October 2024 and is set to expire in September.
• Batch GQQ24067, containing 28 tablets, was manufactured in October 2024 and is set to expire in September.

Speaking to your pharmacist or provider

Patients who are using Arya Enalapril 10mg are advised to check the batch number printed on their medication packaging to see if they have one of the affected batches. If a patient finds they have a recalled batch, they should contact their pharmacist or a healthcare provider. They can discuss the situation and, if needed, arrange for an alternative medication. It is important for patients not to discontinue their blood pressure medication abruptly without first speaking with a doctor, pharmacist or another qualified healthcare professional.

Sahpra has also directed healthcare professionals, pharmacies, wholesalers and any other suppliers of medicine to promptly identify any stock from the recalled batches. They are instructed to cease dispensing, selling or distributing these products and to set aside the affected stock. The recalled medicines are then to be returned through the existing supply chain, following the specific instructions provided by Arya Pharma for the recall. 

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