SAHPRA recalls batches of Benylin pediatric cough syrup

According to the SAHPRA, diethylene glycol is toxic to humans when consumed and can prove fatal.

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

On 10 April 2024, the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) reported to the concerned party that a batch of Benylin paediatric cough syrup had high levels of diethylene glycol detected in it.

According to the SAHPRA, 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.

“SAHPRA immediately contacted the 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,” the local drug watchdog explained.

SAHPRA, in collaboration with Kenvue, has identified the affected batch numbers as 329304 and 329303.

These affected batches have been distributed to several countries including South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, said 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. 

“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 explained.

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.

“SAHPRA wishes to inform 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 (GMP),” said Semete-Makokotlela.

The drug watchdog stressed that the recall is limited to two batches and that the public should not panic regarding the range of products bearing the same name.

“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,” said 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. 

According to SAHPRA, this is a countrywide recall. 

The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or 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 this using the Med Safety App or send an email to adr@sahpra.org.za. 

(With Inputs from South African Government Press Release)