Medicines regulator finds no toxin in recalled cough syrup

An investigation into two recalled batches of children’s cough syrup made in SA by Johnson & Johnson found no trace of a toxin, and no adverse events have been reported from consuming the syrup, the country’s drug regulator said on Wednesday.

The SA Health Products Regulatory Authority (Sahpra) issued the recall in April, days after Nigeria’s regulator recalled the medicine — a batch of Benylin Paediatric Syrup made in SA — over an unacceptably high level of a potentially deadly toxic substance, diethylene glycol.

No adverse events have so far been reported in SA or other African countries relating to the syrup, though Kenya, Rwanda, Tanzania and Zimbabwe also issued recalls.

“Sahpra also wishes to indicate that there is no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in SA or anywhere else where they were exported to on the continent,” the regulator said in a statement.

Kenvue, which owns the Benylin brand after a spin-off from J&J in 2023, said its own tests of the recalled batches found no trace of either diethylene glycol or another closely linked toxin, ethylene glycol.

“We welcome the statement by Sahpra reaffirming the safety of the batches of Benylin Paediatric Syrup that were subject to the recall,” it said in a statement.

The contaminant diethylene glycol, and ethylene glycol, have been linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan since 2022. There is no evidence that those incidents were linked with the recalls in April.

Reuters