The Citizen (KZN)

Sahpra tells public not to panic after cough syrup recall

- Faizel Patel

The South African Health Products Regulatory Authority (Sahpra) has recalled two batches of Benylin cough syrup after high levels of diethylene glycol were discovered in the medicine.

Sahpra said it had received a report from Nigeria’s National Agency for Food and Drug Administra­tion and Control about the detection of high levels of the substance in Benylin.

It said the affected products have the batch numbers 329304 and 329303 and have been distribute­d to South Africa, Eswatini,

Rwanda, Kenya, Tanzania and Nigeria.

Sahpra chief executive Boitumelo Semete-Makokotlel­a said it had contacted the medicine’s South African manufactur­er, Kenvue (formerly Johnson & Johnson), for a response.

“Following engagement­s with the manufactur­er, and in the best interests of the public, it was resolved that affected batches would immediatel­y be recalled while an investigat­ion is ongoing,” she said.

Sahpra urged the public not to panic as the matter was being handled with priority.

“Batch recalls are batch-specific and do not necessaril­y apply to other batches/similar products. The manufactur­er is a Sahpra-licensed manufactur­er and complies with Good Manufactur­ing Practices. The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name.”

The regulation body said the recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequenc­es.

“This is a countrywid­e recall. The product is being recalled from hospitals, retail outlets, healthcare profession­als, authorised prescriber­s and individual customers or patients.”

Semete-Makokotlel­a said the “toxic effects [of diethylene glycol] 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

“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,” she added.

“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,” said Semete-Makokotlel­a.

Benylin Paediatric Syrup presents as a clear, bright-red syrup that has a raspberry aroma and taste.

It is packed in amber glass bottles containing 100ml with a plastic measuring cup.

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