South Africa’s health regulator has announced a recall of Johnson & Johnson’s children’s cough syrup following detection of high levels of diethylene glycol.
The affected batches were distributed not only in South Africa but also in several other African nations including Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.
The decision to recall the product came after the regulator’s counterpart in Nigeria reported the presence of the toxin in a batch of Benylin Paediatric Syrup.
Both Kenya and Nigeria have already initiated recalls for the same syrup, which is commonly used in the treatment of hay fever and other upper respiratory tract conditions.
South Africa Gives Reason for Recall
The decision to recall the cough syrup stems from findings by Nigeria’s health regulatory authority, which initially detected elevated levels of diethylene glycol in a batch of Benylin Paediatric Syrup, a product under the Johnson & Johnson umbrella.
Kenya and Nigeria had already taken preemptive measures by issuing recalls for the same syrup.
Kenvue, the entity now responsible for the Benylin brand following its spin-off from Johnson & Johnson last year, has responded swiftly to the concerns.
In a statement, Kenvue affirmed its commitment to public health, announcing its collaboration with health authorities to assess the situation and determine the appropriate course of action.
Notably, the company highlighted its review of the global safety database, spanning from the product’s release in May 2021 to April 11, 2024, which did not reveal any serious adverse events associated with the Benylin Paediatric Syrup during this period.
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“A review of our global safety database for the period between product release in May 2021 and up to 11 April 2024 did not identify any serious adverse events for any batch of Benylin Paediatric Syrup,” it said.
Tragically, diethylene glycol has been linked to numerous deaths, particularly among children, in various countries including Gambia, Uzbekistan, and Cameroon since 2022.
Kenya Recall Cough Syrup
On April 11, 2024, the Pharmacy and Poisons Board (PPB) of Kenya took action, issuing a public alert demanding the immediate recall of Benylin pediatric 100mls cough syrup Batch No 329304.
Manufactured by Johnson & Johnson in South Africa, this particular batch came under scrutiny after the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria uncovered alarming levels of diethylene glycol, a highly toxic substance known to pose serious health risks, including potential fatality.
The PPB’s directive came in response to NAFDAC’s findings, which revealed an unacceptable concentration of diethylene glycol in the implicated cough syrup.
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This toxin, when ingested, can trigger a range of adverse effects, from abdominal discomfort and vomiting to more severe manifestations such as acute kidney injury and altered mental states, with fatal consequences.
In its public statement, the PPB stressed the urgent need for the recall, citing quality concerns arising from the presence of diethylene glycol in the Johnson & Johnson-manufactured product.
“This cough syrup manufactured by Johnson & Johnson (Pty), South Africa, is being recalled due to quality concerns arising from an unacceptable high level of diethylene glycol detected through laboratory analysis conducted by NAFDAC.” noted the PPB in the statement.
