The South African Health Products Regulatory Authority (SAHPRA) announced in a statement the recall of two batches of Benylin baby syrup manufactured by the US-based Johnson & Johnson subdivision Kenvue due to high levels of diethylene glycol.
"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 is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events," the statement said.
SAHPRA said it took the action after receiving a report from Nigeria's National Agency for Food and Drug Administration and Control on the toxicity of the baby syrup.
The health agency added that the recall is nationwide and includes hospitals, retail stores, healthcare professionals, authorized 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," the authority pointed out.
According to SAHPRA, in addition to South Africa and Nigeria, affected batches of Benylin syrup have been distributed to Ethiopia, Rwanda, Kenya and Tanzania.
This is not the first time that Johnson & Johnson has been in the spotlight for negative consequences in South Africa: in September 2023, the South African Competition Commission launched an investigation into the artificial extension of patents by the US pharmaceutical company in order to monopolize the country's market.
In addition, last June, Johnson & Johnson baby powder was recalled by Rwanda's Food and Drug Administration over allegations that the company's products cause cancer and that the talcum powder from which they are made contains the dangerous element asbestos.