The South African Health Products Regulatory Authority (SAHPRA) has initiated a recall for two batches of Kenvue’s (previously Johnson and Johnson) Benylin paediatric syrup, indicated for cough relief in children.

The recall is in response to detecting high levels of diethylene glycol in the medicine, which poses serious health risks.

SAHPRA classified the country-wide recall as Class 1, Type A – a severe product quality concern that could have dire consequences.

The issue came to light following a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), which found the toxic substance in a batch of syrup.

Working with Kenvue, SAHPRA has identified the impacted batch numbers as 329303 and 329304. These batches were distributed across Eswatini, Kenya, Nigeria, Rwanda, South Africa and Tanzania.

Benylin paediatric syrup is a raspberry-flavoured red syrup, packaged in 100ml amber glass bottles with a plastic measuring cup, to relieve cough, congestion, hay fever and allergies affecting the upper respiratory tract.

SAHPRA has urged healthcare professionals and the public to cease using the affected batches, remove them from inventory and return them through normal distribution channels immediately.

The recall extends to hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.

Diethylene glycol is highly toxic if ingested and can lead to symptoms such as pain in the abdomen, vomiting, diarrhoea, headaches and acute kidney injury, potentially resulting in death.

The authority emphasised that the recall is batch-specific and does not necessarily apply to other batches or similar products.

SAHPRA CEO Dr Boitumelo Semete-Makokotlela stated: “As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public.

“SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events.”

A Kenvue spokesperson said: "The health and safety of the people who use our products is our top priority. We do not sell the product “Benylin® Paediatric Syrup” or the specific product formulation in the UK. 

We are engaging with the National Agency for Food and Drugs Administration and Control (NAFDAC) in Nigeria to understand more as we conduct our own assessment, including verifying the authenticity of the sampled product, testing methodology used and results reported by the agency. We are working with health authorities to determine the appropriate course of action."

Note: This article was updated after publication to incorporate a statement from Kenvue.