New Zealand-based a2 Milk Company (a2MC) is recalling three batches of its infant formula sold in the United States, citing the presence of cereulide toxin.
The recall is applicable to a2 Platinum Premium infant formula, zero to 12 months, milk-based powder with iron, the company said in an announcement published by the Food and Drug Administration on May 2.
“Cereulide is a heat-stable toxin produced by some strains of the bacterium Bacillus cereus. Illness occurs through the consumption of food contaminated with the toxin and preparing formula with hot water does not eliminate it,” it said.
“Symptoms typically develop within 30 minutes to six hours of ingestion and most often involve gastrointestinal symptoms such as nausea and vomiting that typically self-resolve within 24 hours. Infants are at greater risk due to their developing immune systems and can experience complications such as dehydration which require medical care.”
Recalled products were sold in 31.7 oz. tins with batch number 2210269454 and “Use By” date of July 15, 2026; batch number 2210324609 with date Jan. 21, 2027; and batch number 2210321712 with date Jan. 15, 2027.
More than 63,000 units of infant formula were tagged across these three batch numbers, out of which 16,428 units are estimated to have been sold to customers.
The items were distributed nationwide via the A2MC website, Amazon, and Meijer stores as part of the Biden-era Operation Fly Formula that sought to tackle a shortage of infant formula products.
Importation rights for the recalled products ended on Dec. 31, 2025, and as a result, the product had already been discontinued and had been removed from sale in the United States before the recall was initiated.
“The recall was initiated by a2MC after cereulide was detected through additional testing of the Product conducted in response to new guidance issued by New Zealand’s food regulatory authority. The probable source of cereulide is an ingredient in the Product,” the announcement said.
“Consumers who have purchased the Product are recommended to discontinue use of the Product and dispose of it immediately or return to their place of purchase for a refund. If your infant is experiencing symptoms described above, contact your health care provider immediately.”
Customers with queries can contact the company at 1-844-422-6455.
The Epoch Times reached out to a2 Milk Company for comment but did not receive a response by publication time.
According to a Jan. 30 post by Singapore’s Communicable Diseases Agency, cereulide is a highly heat-stable toxin. As such, it is unlikely to be destroyed or deactivated by cooking, including when preparing infant formula. Even a formula that is properly prepared can end up causing illness in infants.
Symptoms of cereulide poisoning among infants include diarrhea, vomiting, cramps, abdominal pain, and distress within hours of consuming the contaminated formula. The babies may refuse feeding, show signs of dehydration, and become lethargic.
“While most cases resolve without treatment within 6 to 24 hours, severe cases (usually persistent, frequent or intense symptoms) can be life-threatening if left untreated, just like other causes of food poisoning in infants,” the post said.
“Parents should seek immediate medical attention if their infant shows symptoms of persistent vomiting, diarrhoea, or distress after consuming contaminated infant formula, and should not wait to see if symptoms improve. This is particularly important if symptoms are severe.”
According to the post, treatment of cereulide toxicity is focused on managing the symptoms and offering supportive care, such as controlling diarrhea and managing dehydration via fluid replacement. Most individuals fully recover from cereulide poisoning without having to receive medical treatment.
Cereulide was the focus of a major international infant formula recall in January, when three global dairy brands—Nestle, Lactalis, and Danone—announced the withdrawal of their products due to potential contamination.
A Chinese biotech company from Wuhan, Cabio Biotech, was identified as the manufacturer of the arachidonic acid oil linked to the cereulide contamination. Cabio Biotech cooperates with international distributors such as Cargill to sell its products in more than 30 nations.
In February, the European Commission strengthened import controls on arachidonic acid oil from China.