J&J cough syrup recall noted as most serious in South Africa

South African officials classified the recent product recall of Johnson & Johnson (NYSE:JNJ)-made children’s cough syrup brand Benylin as a Class 1, Type A recall on Saturday, indicating a serious product quality issue.

The South African Health Products Regulatory Authority (SAHPRA) said it has worked with the brand’s current owner, J&J’s consumer care spinoff, Kenvue (KVUE), to identify the affected batches after its Nigerian counterpart initiated the recall a few days ago.

On Wednesday, Nigerian drug regulator the National Agency for Food and Drugs Administration and Control (NAFDAC) announced its decision to recall a batch of Benylin Paediatric Syrup after finding high levels of diethylene glycol, a toxic substance that can lead to acute kidney injury.

SAHPRA said it is recalling two Benylin batches over the issue, which it said have been distributed in South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria.

“We take this matter very seriously and are acting with urgency to conduct a thorough safety and quality assessment,” Kenvue (KVUE) said in a statement.