Jakarta. Indonesia’s Food and Drug Monitoring Agency (BPOM) has ordered PT Nestlé Indonesia to immediately withdraw its S-26 Promil Gold PHPro 1 infant formula from the market following reports of suspected contamination with cereulide toxin in a raw material used in its production.

BPOM said exposure to cereulide toxin can cause serious symptoms, including severe or persistent vomiting, diarrhea, and unusual fatigue, particularly in infants.

The decision follows food safety alerts issued by the European Union’s Rapid Alert System for Food and Feed (RASFF) and the International Food Safety Authorities Network (INFOSAN) over potential cereulide contamination in certain batches of arachidonic acid (ARA) oil, a raw ingredient used in infant formula.

BPOM’s investigation found that infant formula produced by Nestlé Suisse SA at its Konolfingen plant in Switzerland — which was suspected of using the affected raw material — had entered the Indonesian market. The agency tested samples from two batches of the product circulating domestically.

“Laboratory results showed no detectable cereulide toxin in the tested samples,” BPOM said. “However, the recall was ordered as a precautionary measure to prioritize public health protection.”

BPOM head Taruna Ikrar said cereulide is a toxin produced by the bacterium Bacillus cereus and is particularly dangerous because it is resistant to heat.

“This toxin cannot be eliminated through boiling water or normal cooking processes,” Taruna said. “Symptoms generally appear quickly, within 30 minutes to six hours after consumption, and may include severe vomiting, diarrhea and unusual fatigue.”

Indonesia’s move follows similar actions by other regulators. On Jan. 8, the Singapore Food Agency (SFA) directed retailers to stop selling five batches of Nestlé infant and follow-on formula products due to the potential presence of cereulide toxin, while investigations remain ongoing. The SFA said the action followed reports of public recalls issued by several countries over affected batches of infant formula.

Nestlé has since issued a global recall of certain baby formula products, including specific batches of its SMA infant and follow-on formula, citing concerns they may contain cereulide. The company said the affected batches were sold in multiple countries.

“There have been no confirmed reports of illness associated with the products,” Nestlé said in a statement, adding that the recall was carried out “out of an abundance of caution.”

“The safety and wellbeing of babies is our absolute priority,” the company said. “We sincerely apologize for any concern or inconvenience caused to parents, caregivers and customers.”

Cereulide is produced by certain strains of Bacillus cereus, a bacterium commonly found in the environment, including soil and dust, which can contaminate foods such as rice, pasta and dairy products. Under certain conditions, the bacteria can grow and produce toxins that cause food poisoning.

In infants, symptoms can include vomiting, diarrhea, abdominal pain and cramps — often seen as persistent crying or refusal to feed — as well as lethargy and signs of dehydration within a few hours of consumption. While most cases resolve within 6 to 24 hours without treatment, severe or persistent symptoms can be life-threatening if left untreated.

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