Batches of baby formula have been recalled due to possible health risks.

The Food and Drug Administration (FDA) issued a notice on Saturday, May 2, that the a2 Milk Company has voluntarily recalled three batches of its a2 Platinum Premium USA 0-12 months tins.

The presence of the toxin cereulide was found during product testing that was done to comply with new guidance from New Zealand’s food regulatory authority.

The infant formula product was only sold in the US and had been “distributed nationally through a2MC’s website, Amazon and Meijer stores as part of Operation Fly Formula.”

“Importation rights expired on December 31st, 2025, and the Product has been discontinued and removed from sale prior to the initiation of the recall,” the company announcement said.

In the three batches recalled, a total of 63,078 units were affected, with an estimated 16,428 units sold to consumers.

The milk-based powder formula is designed for infants up to 12 months old and comes with added iron.

The affected batches, sold in 31.7oz tins, have use-by dates of July 15, 2026, January 15, 2027 and January 21, 2027. Batch numbers concerned include 2210269454, 2210324609 and 2210321712.

According to the Cleveland Clinic, cereulide, a toxin produced by strains of a type of bacteria called Bacillus cereus, can cause food poisoning and lead to diarrhea, vomiting and stomach pains.

Cereulide is heat-stable, so preparing formula in hot water won’t get rid of the toxin, the FDA noted.

Food poisoning can cause greater problems in babies since their immune systems are not fully developed and they can lose a lot of fluid very quickly, leading to complications such as dehydration.

The FDA advised anyone concerned about their children to seek medical attention immediately.

There have been no confirmed reports of illness, but the FDA suggested consumers to discard the formula or return it to the place of purchase of a full refund.