The National Agency for Food and Drug Administration and Control has clarified that there are no records of children dying or falling ill from exposure to a batch of Benylin Paediatric cough syrup manufactured by Johnson & Johnson, a senior official said on Tuesday.

The recall was initiated after laboratory tests revealed an unacceptably high level of diethylene glycol, a potentially toxic substance, prompting regulators in five other African countries to recall the syrup.

Director of Pharmacovigilance at NAFDAC, Fraden Bitrus, explained that recent child deaths in other African countries linked to contaminated medication prompted increased cough syrup testing, but there were no specific reports of harm to children in Nigeria.

“We sampled several products. Some failed, and some passed. This particular product had been sampled earlier but we were not thinking of diethylene glycol and because of this, we decided to test the product again,” Bitrus said.

Consuming diethylene glycol can result in acute kidney injury and has been linked to deaths of children in several countries since 2022.

The recalled batch of Benylin Paediatric syrup was made by J&J in South Africa in May 2021, although Kenvue now owns the brand after a spin-off from J&J last year.

Asked about investigations into the issue, Joe Wolk, chief financial officer of J&J, mentioned that the focus is currently on Kenvue.

Kenvue has stated that it is conducting assessments and collaborating with health authorities to determine the next steps.

Following Nigeria’s announcement last week, Kenya, South Africa, Tanzania, Rwanda, and Zimbabwe all recalled the same batch of syrup, with South Africa also recalling an additional batch.