Benylin Paediatric Syrup (each 5 ml contains 7 mg Diphenhydramine HCl)

Reason for recalls

On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from National Agency for Food and Drug Administration and Control (NAFDAC) regarding detection of high levels of Diethylene glycol in a batch of Benylin Paediatric medicine. SAHPRA immediately contacted the manufacturer Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer, it was resolved that affected batches would immediately be recalled whilst investigation is ongoing.

SAHPRA, in collaboration with the South African manufacturer, Kenvue (Johnson and Johnson) have identified the affected batch numbers as 329304 and 329303 and identified the following countries to which these batches have been distributed: South Africa, Eswatini, Rwanda, Kenya, Zambia, Tanzania and Nigeria.

Advice to HCPs/Distributors/Public

The company urges the public and requests all their clients to refrain from selling or consuming any of the affected batches of Benylin® Peadiatric Syrup and to return these to their supplying warehouse or distributor for full credit with immediate effect.

Proposed action taken and its urgency:

A SAHPRA approved recall letter has been distributed to all distribution points and the recall process has been initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.