Over the past month, three international infant formula manufacturers have had to issue global recalls for specific product batches, due to the potential presence of the toxin cereulide. As investigations continue, more batches are being added to the list. Food safety is critical, particularly for vulnerable consumers, but who is responsible for ensuring products are up to standards?
So far, seven batches have been recalled in Australia, with no reported cases of illness. But the incidents have highlighted the convoluted nature of the recall process, and the importance of streamlining the country’s food safety management.
Laying out the facts
Nestlé initially discovered low levels of cereulide in product samples from its factory in the Netherlands in late November 2025, which was confirmed in finished batches by early December. The company stated it notified all potentially impacted countries of its analysis and began the European recall on 10 December. The Australian recall was not announced until almost a month later, on 7 January 2026.
Cereulide is a heat-stable substance produced by the Bacillus cereus microorganism, which can cause symptoms of vomiting, diarrhoea or unusual lethargy if ingested. These symptoms can appear between 30 minutes to 6 hours after exposure and typically resolve within 24 hours.
Nestlé confirmed on 29 December 2025 that the contamination came from arachidonic acid oil (ARA) in an oil blend sourced from a global industry supplier and used to produce infant formula in several Nestlé factories. From there, the company individually tested oil mixes to identify the batches that needed to be recalled. Authorities in affected countries were notified from 2 January.
On 17 January, the Singapore Food Agency reported it had detected cereulide toxin in two additional products, after stepping up surveillance and testing of imported infant formula. This included another Nestlé product, and a product owned by Danone, another European producer.
On 22 January, Lactalis also began recalls of select batches across 18 countries, including two in Australia. Danone stated on 24 January it will withdraw “a very limited number of specific batches of infant formula products”, although there has been no notice for the Australian market at time of writing. Both Nestlé and Danone widened their recalls in the past week, following the European Food Safety Authority setting a threshold for cereulide levels.
European investigations reportedly showed some batches of contaminated products from the three companies had been on shelves for months, even up to a full year, prior to recall.
Australian situation
In Australia, five batches of Nestle Alfamino formula and two batches of Sanulac Nutritionals Alula formula (owned by Lactalis) were recalled nationally due to the potential presence of cereulide. The Nestlé recall was announced on 7 January, and the Sanulac recall on 22 January.
Food Standards Australia New Zealand (FSANZ) said it was coordinating an Australia-wide recall for both products, following the international recalls. It added that up to 22 January, there have been no reports of associated illness in Australia.
While Alfamino formula was not sold in supermarkets, it was available through hospitals, pharmacies and GPs. FSANZ speculated a small amount could have been bought over the counter at pharmacies or online. The Alula products subject to the recall were sold at Coles, Woolworths, Big W, IGA, Costco, pharmacies, and Amazon nationally and online.
Both recalls were only conducted due to the international manufacturer notifying Australia of the potential contamination. Although other countries have begun their own testing and investigation process, it is difficult to determine if Australian authorities are working to confirm any other related product issues – due to the confusing process of enforcing domestic food safety policies.
In Australia, ministers responsible for food regulation set policy, which is then developed by FSANZ into the Food Standards Code, which is subsequently enforced by state and territory food agencies, and the Department of Agriculture, Fisheries and Forestry (DAFF) for imported foods.
In 2024, the Infant Nutrition Council stated that 20-40 per cent of infant formula products and inputs in Australia were imported. These products are classified as a surveillance food by DAFF, with the department stating it refers consignments for analytical testing at the rate of five per cent, where a visual and label assessment are also conducted.
However, a spokesperson from DAFF told Food & Drink Business (F&DB) that existing testing arrangements would not detect the presence of cereulide.
“DAFF is currently considering changes to better manage food safety risks with imported infant formula products. The department is not aware of this issue affecting other brands of imported infant formula,” the spokesperson said.
Even if the products had been tested coming into Australia, the presence of cereulide would not be detected, and will not be detected if contaminated products come through in future, until the department determines if a change will be made.
When asked if there was an idea of how much contaminated formula made it into Australia, DAFF declined to comment.
It raises the question that once the imported food product arrives in the country, what investigation process is undertaken.
According to the FSANZ Act: “When FSANZ is notified of a food recall, it liaises with the food business and relevant state and territory governments to gather and collate all necessary information. This information is then disseminated to state and territory governments, other government bodies (including the ACCC) and the food industry.”
A spokesperson from FSANZ told F&DB: “While we set the standards in the Code, we do not enforce them. Similarly, while we coordinate food recalls nationally, we do not have powers to enforce them or lead related investigations. This too is the responsibility of state and territory food regulatory agencies.”
It falls to the individual state and territory governments to enforce the recalls and investigate further issues.
A spokesperson from the NSW Department of Primary Industries and Regional Development (DPIRD), the state department responsible for food regulation in New South Wales, told F&DB that: “The NSW DPIRD understands the impacted importers are engaging with FSANZ to manage the recall of affected products. DPIRD is continuing to work with impacted importers.”
It is unknown to what extent, if any, the state and territory governments are testing and investigating the issue, outside of that being carried out with the manufacturers that flagged their products – even as international recalls widen and other countries implement their own testing processes.
The disconnected nature of the current food safety and recall system is not a new issue – industry has been clamouring for a national food plan and national food council for over a decade. As of early 2025, Australia has been taking steps towards these goals, with the newly formed food council meeting for the first time in December. However, it remains to be seen what issues the council will prioritise, if the food plan will be effective, and how quickly the country can begin streamlining the policy process.
