Multiple African countries have issued a recall for a batch of Johnson & Johnson children’s cough syrup due to laboratory tests finding elevated levels of toxicity.

“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,” Reuters reports.

Drug regulators in Tanzania, Rwanda, Kenya, South Africa, and Zimbabwe also issued recalls of the drug.

African states recall Johnson & Johnson children’s medicine
Kenya has followed Nigeria in withdrawing a batch of cough syrups, saying they contain deadly toxins

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RT reports:

On April 12, the Tanzania Medicines and Medical Devices Authority (TMDA) initiated the recall upon receiving information regarding the Nigerian test findings on the previous day. On the same day, the Rwanda Food and Drugs Authority (FDA) issued “the present recall for precautionary measures.”

The Medicines Control Authority of Zimbabwe (MCAZ) director-general Richard Rukwata stated on Monday that the organization had decided to recall the product.

According to the Nigerian regulator’s report, “laboratory analysis conducted on the product showed that it contains an unacceptable high level of diethylene glycol and was found to cause acute oral toxicity in laboratory animals.”

Diethylene glycol has been reported to cause abdominal pain, an inability to pass urine, and acute kidney injury, which can be fatal.

The batch being recalled was manufactured by JNJ in South Africa in May 2021 and has an expiration date of April 2024, according to the Kenyan Pharmacy and Poisons Board (PPB).

3 more countries join African recall of Johnson & Johnson children cough syrup https://t.co/V6qhypJHDK

— Africa Updates (@africaupdates) April 16, 2024

Zimbabwe has recalled with immediate effect a tainted children’s cough syrup manufactured by Johnson & Johnson which was also sold in six African nations. https://t.co/sTsHVaNWVj

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Per Reuters:

South Africa's drug regulator said on Tuesday that there was no record of adverse reactions in South Africa 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 South African 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.