• SAHPRA has lifted the recall on batches of Benylin cough syrup for children in South Africa.
• It recalled the products from shelves in April following an alert from Nigeria that the cough syrups contained a deadly toxin.
• The ban was lifted as SAHPRA’s investigation concluded that batches of the cough syrup were found to contain none of the toxin.

In April, the South African Health Products Regulatory Authority (SAHPRA) announced wide-ranging recalls of two batches of Benylin paediatric cough syrup from South African shelves.

According to SAHPRA at the time, it received an alert issued by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) that the batches contained high levels of highly toxic diethylene glycol.

The recall would persist as long as the investigation into the batches was ongoing, and now as of June, the investigation has been concluded and the recall is being lifted.

“SAHPRA tested samples of the two affected batches of Benylin paediatric syrup through an independent laboratory and a method developed by the World Health Organisation for testing products for the presence of diethylene glycol,” the authority said in a statement, as per SA News.

“The tests did not find traces of diethylene glycol in the recalled batches,” it added.

Instead, SAHPRA says that the recall was implemented as a precaution to protect lives, while it investigated the reported high levels of diethylene glycol. It detailed that ingesting ethylene glycol could lead to effects like abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, kidney failure, and death.

The compound is most infamously found in antifreeze and has been used as a poison in the past due to its sweet taste and colourless nature.

Despite removing the product, manufactured in South Africa by Kenvue, formerly Johnson and Johnson, from shelves temporarily, SAHPRA says that it is its mandate to investigate health products, and that it applies this due diligence throughout the product lifecycle, from registration to post-market monitoring.

“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

[Image – Photo by Bruno Guerrero on Unsplash]