Kenya and Nigeria have decided to ban a batch of children’s cough syrup made by Johnson & Johnson under the Benylin Paediatric brand because it contains a dangerous substance called diethylene glycol.
Benylin Children’s Cough Syrup is prescribed for the relief of cough and associated symptoms of congestion, as well as to manage hay fever and various allergic conditions in children between the ages of 2 and 12 years.
Nigeria’s health regulator, the National Agency for Food and Drug Administration and Control (NAFDAC), recalled the batch of Benylin identified by number 329304. According to NAFDAC, laboratory tests showed that the syrup contains a high level of diethylene glycol.
On April 10th, 2024, NAFDAC made a public announcement about the recall. They said, “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.”
Just a day after NAFDAC made this assessment Kenya Pharmacy and Poisons Board (PPB) also announced a recall of the same batch of syrup, made by Johnson & Johnson in South Africa in May 2021 with an expiration date of April 2024. The PPB has advised that stores stop selling certain batches of cough syrup and return them to the suppliers.
Diethylene glycol is a dangerous substance that can cause severe symptoms like stomach pain, vomiting, and kidney damage when swallowed. Diethylene glycol has been linked to the deaths of many children in countries like Gambia, Uzbekistan, and Cameroon since 2022.
Kenvue, the company currently overseeing the Benylin brand following its separation from JNJ last year, said it is conducting its assessment to verify the authenticity of the sampled product, testing methodology, and results.
“We take this matter very seriously and are acting with urgency to conduct a thorough safety and quality assessment,” Kenvue said in a statement.
