The South African Health Products Regulatory Authority (SAHPRA) has recalled two batches of Benylin Paediatric Syrup. This was done after elevated levels of diethylene glycol were detected in the cough syrup. The recall will stay in place while an investigation takes place.

SAHPRA was informed by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) about elevated levels of diethylene glycol. Following discussions with Kenvue (formerly Johnson and Johnson), for their input and considering public safety, it was decided to recall the affected batches.

SAHPRA, along with Kenvue, identified the affected batches as 329304 and 329303. These batches were distributed to South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.

Benylin Paediatric Syrup is a clear, bright red syrup with a raspberry scent and taste. It is packaged in amber glass bottles of 100 mL with a plastic measuring cup. It’s used to relieve coughs and congestion, as well as for hay fever and other upper respiratory allergies.

The recall only applies to specific batches and doesn’t extend to other batches or similar products.

“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.”

SAHPRA has also advised healthcare professionals and the public to stop using batches 329304 and 329303. In addition, it should be removed from the medical inventory and returned through proper channels immediately.

This recall is classified as Class 1, Type A, indicating a serious quality concern with potentially severe consequences. It’s a nationwide recall affecting hospitals, retail stores, healthcare providers, authorized prescribers, and individual customers or patients.

Key Information for the Public:

Diethylene glycol is toxic and can be fatal if ingested. Symptoms include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.

“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 CEO, Dr Boitumelo Semete-Makokotlela

Members of the public 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