• Nigeria and Kenya have recalled a batch of Benylin paediatric cough syrup that was reportedly produced in South Africa.
• Nigeria's health regulator says tests found an unacceptably high level of a potentially deadly toxic substance.
• Diethylene glycol has been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon.
• For more financial news, go to the News24 Business front page.

Nigeria’s health regulator has recalled a batch of Benylin paediatric cough syrup that was reportedly produced in South Africa, amid claims that it contains an unacceptably high level of a potentially deadly toxic substance.

Reuters reported on Wednesday that tests on the cough syrup brand had revealed a high level of diethylene glycol, which has been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since 2022, in one of the world’s worst waves of poisoning from oral medication.

The syrup is used to treat cough- and congestion-related symptoms, hay fever and other allergic reactions in children aged two to 12, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) said in a notice on its website.

"Laboratory analysis conducted on the product showed that it contains an unacceptably high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals," NAFDAC said.

Public Alert No. 013/2024.Alert on recall of Benylin Paediatric Syrup in Nigeria#NafdacALERTS?? https://t.co/Nvx0qXawgh pic.twitter.com/QrdmXtrOjr

— NAFDAC NIGERIA (@NafdacAgency) April 11, 2024

Human consumption of the substance could cause symptoms like abdominal pain, vomiting, diarrhoea, headaches and acute kidney injury that may result in death, the regulator added.

On Thursday, Kenya's health regulator also recalled the syrup, Reuters reported.

The Benylin brand was previously owned by Johnson & Johnson, before it - along with the rest of the latter's consumer health business - was spun off as a separate business called Kenvue in August last year.

"We are engaging with the National Agency for Food and Drugs Administration and Control in Nigeria to understand more as we conduct our own assessment, including verifying the authenticity of the sampled product, testing methodology used and results reported by the agency," a Kenvue spokesperson told News24.

The company, however, did not respond to questions about whether this particular batch of the cough medicine was also on shelves in South Africa, and where in the country it was produced.

On the South African pharmacy shelves that News24 checked, the packaging on Benylin cough syrups states that they were manufactured at a Cape Town facility. The packaging still mentions Johnson & Johnson as the manufacturer.

Contacted for comment by News24, Johnson & Johnson said that Benylin Paediatric was not a Johnson & Johnson product, confirming that it was now a product sold by Kenvue.

Kenvue said it was "acting with urgency" to conduct a thorough safety and quality assessment and that the health and safety of its customers were top priorities.

According to Reuters, the batch being recalled in Nigeria was made in May 2021, with an expiration date of April 2024. The Nigerian regulator urged those with bottles from the batch to discontinue use or sale and submit them to its nearest office.

Kenvue, which also owns brands such as Listerine, Neutrogena and Tylenol, recorded $15.4 billion in net sales in 2023, making it the world’s largest pure-play consumer health company by revenue.

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