The South African Health Products Regulatory Authority has issued a recall for specific batches of Johnson & Johnson’s children’s cough syrup due to elevated levels of diethylene glycol, a harmful substance.
The affected batches were distributed in South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria, as stated in a release on Saturday.
This recall follows reports from the Nigerian health regulator earlier in the week, indicating the presence of the toxin in a batch of Benylin Paediatric Syrup.
Kenya and Nigeria have already initiated recalls for the same syrup, commonly used to treat hay fever and other upper respiratory tract allergic conditions.
The presence of high levels of diethylene glycol in cough syrup has been linked to numerous child fatalities in Gambia, Uzbekistan, and Cameroon since 2022, marking one of the most significant outbreaks of poisoning from oral medications worldwide.
Kenvue, the current custodian of the Benylin brand since its separation from Johnson & Johnson in 2023, has remained silent amidst mounting inquiries regarding the recall of children’s cough syrup.
The recalled batch, produced by Johnson & Johnson in South Africa in May 2021 with an expiration date of April 2024, is under intense scrutiny by regulatory bodies.
Their primary objective is to ensure public safety and prevent potential health risks associated with the consumption of the affected syrup. The recall was initiated following an announcement on April 10th, 2024, by Nigeria’s drug regulatory authority, the National Agency for Food and Drug Administration and Control.
NAFDAC’s declaration raised concerns over Benylin pediatric syrup, manufactured by Johnson & Johnson.
Laboratory analysis of the implicated batch, identified by the number 329304, revealed alarming levels of diethylene glycol. This toxic compound is notorious for inducing severe symptoms upon ingestion, including abdominal pain, vomiting, and acute kidney injury.