Attention parents: ‘Toxic’ batches of Benylin kids cough syrup recalled

The South African Health Products Regulatory Authority (Sahpra) has recalled two batches of Benylin paediatric cough syrup.

Last week, the Nigerian National Agency for Food and Drug Administration and Control reported that a batch of Benylin paediatric cough syrup had high levels of diethylene glycol detected in it.

Sahpra says diethylene glycol is toxic to humans when consumed and can prove fatal.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury that may lead to death,” says Sahpra CEO Dr Boitumelo Semete-Makokotlela.

Sahpra immediately contacted South African manufacturer Kenvue (formerly Johnson and 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, in collaboration with Kenvue, has identified affected batch numbers as 329304 and 329303, which have been distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that they protect the health of the public. We are recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” says Semete-Makokotlela.

Benylin paediatric is a bright red syrup with a raspberry smell and taste, packaged in a 100ml amber glass bottle with a plastic measuring cup.

It is used to relieve cough and congestive symptoms and treat hay fever and other allergies affecting the upper respiratory tract.

Semete-Makokotlela urges 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 or similar products. The manufacturer is a Sahpra-licenced manufacturer and complies with Good Manufacturing Practices.

“Sahpra is alerting healthcare professionals and the public to discontinue the use of the two batches mentioned, remove them from their inventory and return them to their normal distribution channels immediately,” says Semete-Makokotlela.

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.

The recall is countrywide and affects hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers and patients.

Those who have consumed these two batches and experienced any adverse reaction or witnessed it in children should consult their healthcare professional and report the use of the product on the Med Safety App or send an email to adr@sahpra.org.za.