Benylin Paediatric Syrup pulled from shelves in South Africa – what you need to know

A hazardous industrial solvent was found in Johnson & Johnson’s Benylin Paediatric Syrup made for children

The South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding detecting high levels of diethylene glycol in a cough syrup.

Diethylene glycol is toxic to humans when consumed and can prove fatal.

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury, which 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 public’s best interest, it was resolved that affected batches would immediately be recalled while an investigation was ongoing,” the response said.

SAHPRA, in collaboration with Kenvue, have identified the affected batch numbers as:

• 329304, and

• 329303.

Distribution of affected batches is to be found in the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

Benylin Paediatric is an amber glass bottle containing 100ml of clear, bright red syrup with a raspberry odour and taste.

It is indicated for relieving cough and its congestive symptoms and treating hay fever and other allergic conditions affecting the upper respiratory tract.

The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.

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 channel(s) with immediate effect.