The World Health Organization (WHO) is poised to escalate its warning concerning contaminated children’s cough syrup manufactured by Johnson & Johnson (JNJ.N), following its discovery in Nigeria two weeks ago.
The Nigerian regulatory agency initiated a recall of a batch of Benylin paediatric syrup after routine testing revealed elevated levels of diethylene glycol, a concerning contaminant.
Although diethylene glycol and its counterpart, ethylene glycol, have been associated with the deaths of over 300 children across Cameroon, Gambia, Indonesia, and Uzbekistan since 2022, there is currently no evidence linking these incidents to the recent recalls.
The WHO warning
The WHO, known for issuing global medical product alerts to prompt vigilance among national authorities, is expected to take similar action pending confirmation of specific details from involved parties.
- The batch of Benylin syrup under recall was produced by Johnson & Johnson in South Africa in May 2021.
- However, following a spin-off from J&J last year, the brand is now owned by Kenvue (KVUE.N).
- Kenvue, in response to inquiries, stated that it had conducted tests on the recalled batch and had not detected either diethylene or ethylene glycol.
In a statement, Kenvue emphasized its cooperation with health authorities and the WHO, expressing willingness to collaborate with Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) to verify test results and ensure product authenticity.
Since Nigeria’s recall, five other African nations – Kenya, Rwanda, Tanzania, Zimbabwe, and South Africa – have also removed the product from shelves.
- South Africa’s regulatory body has additionally recalled a separate batch of the syrup.
- While diethylene glycol poses significant health risks, including acute kidney failure when ingested, no adverse effects have been reported in the current incident.
Investigations into the contamination of the syrup in Nigeria are underway, with the WHO collaborating with both the manufacturer and South Africa’s regulatory authority. Kenvue has asserted its adherence to rigorous testing protocols for ingredients before manufacturing.
Concerns about counterfeit products are being considered as part of ongoing investigations. The WHO recently issued an alert regarding contaminated cough syrup ingredients discovered in Pakistan, emphasizing the importance of caution among manufacturers.
Propylene glycol, which is not an ingredient in Benylin paediatric syrup, was the focus of the WHO’s recent alert.
