Drug regulatory agencies in Tanzania, Rwanda, and Zimbabwe have initiated a recall of a particular batch of Johnson & Johnson children’s cough syrup as a precautionary measure. This action follows a similar recall by Nigeria, Kenya, and South Africa after laboratory tests conducted by the Nigerian regulatory authority revealed elevated levels of toxicity in the syrup. The affected batch, used for treating coughs, hay fever, and allergic reactions in children, has also been associated with a heightened presence of diethylene glycol, a substance linked to fatal poisoning incidents in several countries since 2022. Diethylene glycol poses a severe risk of acute kidney failure when ingested. The recalled batch of Benylin Paediatric syrup was manufactured by J&J in South Africa in May 2021, although the brand is now under the ownership of Kenvue following a spin-off from J&J last year.
The Tanzania Medicines and Medical Devices Authority (TMDA) initiated the recall on April 12 in response to the Nigerian findings, emphasizing that it is a precautionary measure aimed at swiftly removing the affected drugs from the market. Meanwhile, Kenya’s drug regulatory agency is expected to release its test results on the syrup by Wednesday. Despite no adverse events reported in their safety database, the Rwanda Food and Drugs Authority issued a recall as a precautionary measure. Zimbabwe’s Medicines Control Agency expressed concerns about the possibility of the syrup entering the local market illegally and pledged to enhance inspections accordingly.
Kenvue stated that it is conducting its assessment of the situation and collaborating with health authorities to determine appropriate measures moving forward.