At the weekend the South African Health Products Regulatory Authority (SAHPRA) recalled a popular over-the-counter cough syrup, Benylin Paediatric Syrup. The recall means that retailers, doctors and hospitals must stop dispensing the medicine immediately. This follows Nigerian National Agency for Food and Drug Administration warnings by the Nigerian National Agency for Food and Drug Administration that it found high levels of diethylene glycol in some batches of the syrup.

But what is diethylene glycol and why would it lead to a product recall? Health-e News speaks with Andy Gray, a senior lecturer in the division of pharmacology and discipline of pharmaceutical sciences at University of Kwa-Zulu-Natal to learn more. 

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What is diethylene glycol and how commonly is it found in medication?

It is an industrial chemical used in a wide variety of products such as anti-freeze which is added in motor car radiators in cold climates. It should never be used in medicines. 

How dangerous is it for adults and children when consumed? 

Diethylene glycol, when consumed can cause abdominal pains, vomiting, diarrhoea, being unable to pass urine, headaches, altered mental state and kidney damage which can lead to death. This is in both adults and children.

How can a person identify the recalled cough syrup?

It is a Schedule 2, 100ml Benylin paediatric, raspberry flavoured. The syrup is clear bright red syrup and comes in a glass bottle. It is used to treat congestive, cough symptoms, hay fever and other allergic conditions that affect the upper respiratory tract in children. (A Schedule 2 medicine is available over the counter without a prescription) 

SAHPRA with Kenvue (previously known as Johnson & Johnson) have identified the affected batches in South Africa. Bottles marked 329304 and 329303 have been removed from all South African pharmacies, hospitals, and retail outlets. 

All healthcare professionals, individual customers and patients are requested to safely discard the medicine while their investigation is ongoing. (You can do this by taking it to your nearest pharmacy)

Members of the public including children who have consumed these two batches and are presenting symptoms must consult their healthcare provider and report it to adr@sahpra.org.za

Has the quantity of diethylene glycol increased in the cough syrup? 

At this stage it is unclear whether the error occurred with the wrong ingredient being included, or whether the correct ingredient was used. But it is certain that the medicine was contaminated with diethylene glycol. – Health-e News