SWITZERLAND — The World Health Organization (WHO) is set to issue an expanded warning regarding contaminated children’s cough syrup manufactured by Johnson and Johnson following its discovery in Nigeria last week, the organization revealed in a recent email.
Nigeria’s regulatory body initiated a recall of a batch of Benylin syrup last Wednesday after routine testing revealed elevated levels of diethylene glycol in the product.
While diethylene glycol, along with a closely related toxin, has been associated with the deaths of over 300 children in Gambia, Uzbekistan, Indonesia, and Cameroon since 2022, there is presently no evidence linking these incidents to the recent recalls.
The WHO has indicated that it intends to issue global medical product alerts to prompt vigilance among national authorities, pending confirmation of specific details from involved parties.
The recalled batch of Benylin syrup originated from J&J’s facilities in South Africa in May 2021. However, Kenvue currently owns the brand following its spin-off from J&J last year.
J&J has deferred comment requests to Kenvue, which was not immediately available for comment. However, the company stated this week that it was conducting its own assessment and collaborating with health authorities to determine the appropriate course of action.
Since Nigeria’s recall, five other African nations—Rwanda, Kenya, Tanzania, Zimbabwe, and South Africa, where the product was manufactured—have also removed the syrup from shelves.
Additionally, South Africa’s regulatory authority has recalled another batch of the syrup, which is commonly used to treat coughs, hay fever, and allergic reactions in children.
While diethylene glycol can lead to acute kidney failure when ingested, there have been no reports of harm associated with the recent incident.
In the 2022 cases, contamination in the syrups stemmed from the raw materials sourced from manufacturers in India and Indonesia.
The WHO affirmed its collaboration with both the manufacturer and regulatory authority in South Africa to investigate the Benylin pediatric syrup.
Information regarding the source of the raw ingredients used was disclosed to the WHO, although the specific source was not revealed.
According to the WHO, Kenvue asserted that it had tested the raw ingredients prior to production, with no notable issues identified.
The possibility of counterfeit syrup is also under consideration in ongoing investigations.
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