Cereulide found in The a2 Milk Company’s infant formula

Baby bottler with milk isolated on white background. Studio shot.
Heat-stable toxin cereulide was found in infant formulas manufactured by several companies earlier this year, including industry giants Nestle and Danone. (Image: Getty/Pidjoe)

New Zealand-headquartered The a2 Milk Company (a2MC) is recalling three batches - or 63,078 tins - of its a2 Platinum Premium Infant Formula 0-12 months USA label due to the presence of cereulide, a heat-stable toxin.

The company wrote in its New Zealand Exchange filing yesterday (May 4) that the products, manufactured by New Zealand-based Synlait Milk Limited, were only sold in the United States via a2MC’s website, Amazon, and Meijer stores as part of Operation Fly Formula.

It added that its importation rights to the US as part of the Operation had expired on 31 December 2025. As such, the products had been discontinued and removed from sale before the recall was initiated.

Of the 63,078 tins implicated in the voluntary recall, an estimated 16,428 tins have been sold to consumers.

The company said that no confirmed incidents of infant illness or harm have been reported so far.

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The recall was initiated after cereulide was detected through additional testing of the products following the release of the New Zealand Ministry for Primary Industries (MPI) industry update and expectations for managing cereulide on 15 April 2026.

“a2MC is communicating with U.S. Food and Drug Administration with respect to the recall and has released guidance to its United States consumers about actions they should take if they have purchased the Product.”

Cereulide is a substance of bacterial origin that causes foodborne illness and is created by certain strains of the microorganism Bacillus cereus. 

The heat-stable toxin can cause severe or persistent vomiting, diarrhea or unusual lethargy, which appear between 30 minutes and six hours after ingestion.

According to the US FDA’s announcement on May 2, the batches affected have a use-by date of July 15, 2026, January 15, 2027 and January 21, 2027, with batch number of 2210269454, 2210321712 and 2210324609 respectively.

Cereulide became a concern in infant formulas after several multinationals, including Nestle, Danone and Lactalis pulled products off shelves earlier in January.

Cereulide was reportedly found in contaminated arachidonic acid (ARA) oil used during the production of infant formulas.

The a2MC did not specify the source of cereulide and has only mentioned that it could be an ingredient in the product.

Different formulation from other markets

The a2MC stressed that products sold outside of the US were not affected by the recall, as the USA label products have “a different formulation and relevant ingredient to the English label a2 Platinum infant formula” sold in Australia, New Zealand, South Korea, Vietnam and through cross-border channels into China.

“The Company confirms that all a2 Platinum products sold outside the United States are unaffected,” it said.

On May 3, the Chinese Customs also said that no such products were found to be imported into China through general trade channels.