More than 63,000 containers of A2 Platinum Premium Infant Formula have been recalled in the US after testing identified contamination with cereulide, a toxin produced by certain strains of Bacillus cereus.

The voluntary recall, issued by the A2 Milk Company, covers three imported batches of its 0-12 months milk-based powdered infant formula with iron, sold in 31.7oz tins. An estimated 16,428 units are believed to have reached consumers through distribution channels including the company’s website, Amazon and Meijer stores under Operation Fly Formula.

The affected batch numbers are 2210269454 (use by 15 July 2026), 2210321712 (use by 15 January 2027), and 2210324609 (use by 21 January 2027). Batch and expiry details are printed on the base of each tin.

According to the company, cereulide is a heat-stable toxin that is not destroyed during formula preparation, including when hot water is used.

The toxin can cause foodborne illness, with symptoms such as nausea and vomiting typically appearing within 30 minutes to six hours of consumption and resolving within 24 hours in most cases. Infants are considered more vulnerable to complications such as dehydration due to their developing immune systems.

The recall was initiated after additional testing carried out in response to updated guidance from New Zealand’s food regulatory authority. The company said the likely source of the contamination is an ingredient used in the product.

No confirmed illnesses or adverse events have been reported to date. However, the company is advising consumers not to use products from the affected batches.

The recall affects a total of 63,078 units across the three batches. The product has already been discontinued and removed from sale, as importation rights expired at the end of December 2025.

The action is being undertaken with the knowledge of the US Food and Drug Administration.