Consuming diethylene glycol is toxic to humans and potentially fatal, leading to symptoms such as abdominal pain, vomiting, and even death. Other effects include headaches and kidney injury.
Sahpra has classified the recall as Class 1, Type A, which is associated with a serious product quality concern that may have severe consequences.
It is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.
Since being alerted of the issue by a Nigerian health regulator, both Sahpra and the South African manufacturer Kenvue - formerly known as Johnson and Johnson - investigated the claim, and found the tainted products have been distributed to South Africa, eSwatini, Rwanda, Kenya, Tanzania, and Nigeria.
Batches 329303 and 329304 are affected.
Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100ml with a plastic measuring cup. It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions 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 organisation said in a media statement.
"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," it added.
"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."
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.
