J&J cough syrup contamination with Diethylene Glycol – WHO may widen alert after recalls in Africa

J&Js paediatric cough syrup Benylin is being recalled in several African countries following detection of high level of diethylene glycol contamination. The recall was triggered in Nigeria (April 10, 2024) after laboratory tests on a batch of  Benylin Paediatric showed a high level of diethylene glycol and found to cause acute oral toxicity in laboratory animals. The batch was made by J&J in South Africa in May 2021 with an expiration date of April 2024. The brand Benylin is now owned by Kenvue after a spin-off from J&J in 2023. After receiving a report on the high levels of Diethylene Glycol from from NAFDAC (Nigeria), the South African Health Products Regulatory Authority (SAHPRA) in collaboration with Kenvue, identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria. Following the engagement with Kenvue SAHPRA resolved that affected batches would immediately be recalled in the best interest of public while an investigation is ongoing. SAPHRA classified the recall as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences.

Since the recall by Nigeria and South Africa, other African countries have also pulled the product from shelves – Kenya, Rwanda, Tanzania, Zimbabwe. Reuters reports that WHO is likely to issue a wider warning about J&Js contaminated cough syrup Benylin

WHO had issued high alerts in 2023 regarding cough syrups manufactured in India due to contamination with Diethylene Glycol (DEG) or Ethylene Glycol (EG). The Central Drugs Standard Control Organisation (CDSCO) in India promptly launched a probe following WHO’s alert and took several actions to ensure the safety and quality of pharmaceutical products manufactured in India. The measures included, cancellation of licenses of Pharmaceutical companies producing counterfeit drugs, notifying and issuing alert on substandard drugs, implementing mandatory testing of cough syrups in government labs before export, The DCGI (Drug Control General of India) also issued an Advisory to drug manufacturers to ensure GMP and use only Pharma grade excipients in manufacture of drugs.