South African health authorities have issued two major product recalls affecting children and infants, citing safety concerns linked to dietary supplements and a specialised infant formula.
The South African Health Products Regulatory Authority (SAHPRA) announced that all products containing zinc picolinate and selenium intended for children must be withdrawn from shelves and returned by consumers.
The regulator said the recall followed evidence that both substances pose potential health risks when used in paediatric supplements, despite being widely marketed as “immune boosters.”
SAHPRA warned that zinc picolinate can cause unpredictable side effects in children – including nausea, diarrhoea, headaches and vomiting – due to its variable bioavailability.
Selenium, while essential in small amounts, carries a risk of overdose in children, particularly when included in general supplements rather than targeted therapeutic use.
The authority said these products, often sold for colds, flu and skin conditions, qualify as medicines requiring formal registration.
Their sale as complementary medicines is, therefore, illegal. All manufacturers and retailers have been instructed to halt distribution and remove the products from circulation, with a six‑month deadline for full withdrawal.
In a separate development, the Department of Health has recalled a specific batch of Nestlé NAN Special Pro HA Infant Formula (0–12 months) after detecting a possible contamination with cereulide, a toxin produced by Bacillus cereus.
The affected batch – 51660742F3, with a best‑before date of 15 December 2026 – has been on the South African market since September 2025.
“The contamination of the product is traced back to the manufacturing plant in Germany, which produces the products for countries, including South Africa,” the health department said.
Authorities confirmed that only this batch reached South Africa and no illnesses have been reported.
Parents have been urged to discontinue use immediately and return the product for a full refund.
The department advised caregivers to monitor infants for symptoms such as persistent vomiting, diarrhoea or unusual lethargy and to consult healthcare providers if concerned.
It also reiterated its support for breastfeeding as the safest and most reliable form of infant nutrition.
Both SAHPRA and the Department of Health said they are working with industry partners and consumer regulators to ensure compliance and maintain public safety as investigations continue.
JN/APA