Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) announced the recall after laboratory tests found an unacceptably high level of diethylene glycol, which is toxic to humans, prompting regulators in five other African countries to also issue recalls.

SA's drug regulator said this Tuesday that there was no record of adverse reactions in SA or anywhere in the world to the two batches of Benylin Paediatric Syrup it recalled.

It said it was conducting tests and investigations, as was manufacturer Kenvue, which now owns the brand after a spin-off from J&J last year.

"We hope to finalise these soon," the SA Health Products Regulatory Authority told Reuters.

Consuming diethylene glycol can result in acute kidney failure. The substance has been linked to 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.

Fraden Bitrus, NAFDAC's Director of Pharmacovigilance, told Reuters the regulator had been testing cough syrups in response to those deaths, not because of any specific report of harm to children in Nigeria.

"We sampled a number of 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," he said.

The recalled batches of syrup were made by J&J in SA in May 2021.

Asked whether J&J was working with Kenvue to investigate what had gone wrong, Joe Wolk, Chief Financial Officer of J&J, told Reuters: "This is just with Kenvue at this point."

Kenvue has said it is working with health authorities to determine next steps.

In addition to Nigeria and SA, regulators in Kenya, Tanzania, Rwanda and Zimbabwe have recalled the same batch of Benylin Paediatric Syrup.

--Reuters--