WHO Confirms Contaminated Benylin Paediatric Syrup Recalled from African Countries

The World Health Organization (WHO) has confirmed that a contaminated batch of Benylin Paediatric Syrup has been recalled from several African countries as of April 23, 2024. The recall was initiated after tests found unacceptable levels of the toxin diethylene glycol in the syrup.

The affected batch, Batch No. 329304, was manufactured in May 2021 in South Africa by Johnson & Johnson, although the Benylin brand is now owned by Kenvue following a spin-off from J&J last year. The syrup was sold in South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria. Five of these countries - Kenya, Rwanda, Tanzania, Zimbabwe and South Africa - have pulled the product from shelves.

Diethylene glycol poses serious health risks, including abdominal pain, nausea, diarrhea, and even kidney malfunction, potentially leading to fatalities. High levels of the toxin in cough syrups have been connected to the deaths of over 300 children in several countries since 2022.

Why this matters: This recall highlights the critical importance of stringent quality control measures in the pharmaceutical industry to safeguard public health. It also emphasizes the need for sustained efforts to prevent similar incidents of contamination, which can have devastating consequences, particularly for vulnerable populations like children.

Kenvue has stated that it has not detected diethylene or ethylene glycol in the recalled batch, but is continuing to work with authorities on the matter. "We have not detected diethylene glycol or ethylene glycol in the retained samples of the batch recalled in Nigeria," a Kenvue spokesperson said.

The WHO initially planned to issue a broader alert about Benylin, but has since decided against it, stating that the recalled batch is no longer on the market and there is no immediate public health risk. However, the organization is collaborating with the manufacturer and South Africa's regulatory authority to investigate the contamination and is considering the possibility of counterfeit products.

The Nigerian regulatory agency, NAFDAC, has advised importers, distributors, retailers, and consumers to exercise caution and vigilance to avoid the importation, distribution, sale, and use of this substandard product. They have directed the Marketing Authorisation Holder, Johnson and Johnson company West Africa, to initiate the recall, which will be uploaded to the WHO Global Surveillance an

Key Takeaways

• WHO recalls contaminated Benylin Paediatric Syrup from several African countries.
• Batch contained unacceptable levels of diethylene glycol, a toxic substance.
• Syrup manufactured in 2021 in South Africa by J&J, now owned by Kenvue.
• Contamination linked to deaths of over 300 children in several countries since 2022.
• Authorities investigating the contamination and possibility of counterfeit products.