SAHPRA recalls Benylin containing toxic, fatal compound, urges public not to panic

The SA 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 on Saturday 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.

Don’t panic

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

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

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

“Batch recalls are batch-specific and do not necessarily apply to other batches/similar products. The manufacturer is a Sahpra-licenced 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 country-wide recall. The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.”

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Toxic effects

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: adr@sahpra.org.za.”

“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,” Semete-Makokotlela said.

Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100 mL with a plastic measuring cup.

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