Drug regulatory authorities in Tanzania, Rwanda, and Zimbabwe have initiated a recall of a batch of J&J cough syrup as a precautionary measure following reports from their Nigerian counterparts indicating high levels of toxicity found in laboratory tests.
The three countries join the list of other African countries including Nigeria, Kenya, and South Africa in the recall of the same batch of syrup, used to treat allergic reactions in children. South Africa has additionally recalled another batch.
Nigeria’s health regulator discovered high levels of diethylene glycol in J&J cough syrup, a substance linked to fatal poisonings in children in Gambia, Uzbekistan, and Cameroon since 2022. This highlights a significant global risk, as diethylene glycol is highly toxic when consumed and can cause acute kidney failure.
The recalled batch of Benylin Paediatric syrup was manufactured by J&J in South Africa in May 2021, although the brand is now owned by Kenvue following a spin-off from J&J last year. The Tanzania Medicines and Medical Devices Authority (TMDA) announced that it commenced the recall on April 12 after being informed of the Nigerian test results.
According to Gaudensia Simwanza, spokesperson for the Tanzania Medicines and Medical Devices Authority (TMDA), the initiative does not involve an investigation but rather the complete withdrawal of the affected medications from the market. Another representative from Kenya’s drug regulatory body mentioned that the test results for the syrup will be available by Wednesday.
In a statement dated April 12, the Rwanda Food and Drugs Authority stated that no adverse events have been reported following a review of the safety database. Nevertheless, the recall is being initiated as a precautionary step.
In Zimbabwe, the country’s Medicines Control Agency stated that there is no record of the drug being imported into the country but expressed concern that it could potentially be smuggled in.
Meanwhile, Kenvue is conducting its own assessment and collaborating closely with health authorities to determine the appropriate course of action.