South Africa’s health regulator said it is recalling batches of Johnson & Johnson’s children’s cough syrup after detection of high levels of diethylene glycol.

According to Reuters, the affected batches were sold in South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria, the statement added.

The recall follows a report by the regulator’s Nigerian counterpart last Wednesday, which first detected the toxin in a batch of Benylin Paediatric Syrup.

Used in the treatment of hay fever

The South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup.

Kenya and Nigeria have already issued recalls for the same syrup, which is used in the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.

Kenvue, which now owns the Benylin brand after a spin-off from J&J last year, said in a statement that it is conducting its own assessment and working with health authorities to determine a course of action.

“A review of our global safety database for the period between product release in May 2021 and up to 11 April 2024 did not identify any serious adverse events for any batch of Benylin Paediatric Syrup,” it said.

High levels of diethylene glycol in cough syrup has been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since 2022 in one of the world’s worst waves of poisoning from oral medication.

What the public should know

Diethylene glycol is toxic to humans when consumed and can prove fatal.

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.

Members of the public who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional and report this using the Med Safety App or send an email to: adr@sahpra.org.za.

Also, let The South African website know.


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