Rwanda, Tanzania recall bad batch of children's cough syrup

Rwanda and Tanzanian drug regulators have joined other African counterparts in recalling a batch of Johnson & Johnson children's cough syrup as a "precautionary measure" after laboratory tests found high levels of toxicity in Nigeria.

The Rwanda Foods and Drugs Authority (FDA) issued a recall on April 12 following the Nigerian test results, the same date the Tanzania Medicines and Medical Devices Authority began its recall, according to separate statements.

Benylin Pediatrics Syrup, with the bad batch in question manufactured by Johnson & Johnson, South Africa, is used to treat coughs, hay fever, and other allergic reactions in children age 2 to 12.

“A review of our safety data base doesn't reveal any adverse events reported for the above mentioned batch. However, Rwanda FDA issues the present recall for precautionary measure,” the regulator said in a statement over the weekend.

The regulator instructed all dealers including importers, wholesalers, retailers, and public as well as private health facilities to stop the distribution and dispensing of the bad batch of the syrup.

It also advised any members of the public in possession of the batch to stop using the medicine.

Rwanda and Tanzania join Nigeria, Kenya, and South Africa in recalling the same batch of the syrup.

Laboratory tests on the syrup in Nigeria showed a high level of diethylene glycol, according to the health regulator.

Diethylene glycol is toxic to humans when consumed and can prove fatal, according to health authorities.

Since 2022, the toxicity has been linked to the deaths of dozens of children in Gambia, Uzbekistan, and Cameroon.

Though the batch being recalled was made by J&J in South Africa in May 2021, since last year Kenvue has owned the Benylin Paediatric syrup brand.

Kenvue said it is conducting its own assessment and working with health authorities to determine a course of action.