Platinum Infant Formula Recall Issued Over Cereulide Toxin Risks

More than 60,000 tins of powdered formula have been recalled due to a potential contamination that poses serious risks to infants.

Federal safety officials are warning parents not to use certain a2 Milk Company infant formula products, after testing identified a toxin that may cause vomiting and dehydration in babies.

The U.S. Food and Drug Administration (FDA) announced the a2 Platinum Premium formula recall on May 2, after cereulide toxins were detected during tests prompted by updated guidance from New Zealand’s food safety authority. The contamination is believed to be linked to an ingredient included in the product.

Infant Formula Contamination

Cereulide is a toxin produced by some strains of Bacillus cereus bacteria, which can cause gastrointestinal symptoms such as nausea and vomiting within 30 minutes to six hours of consumption.

While symptoms typically resolve within 24 hours, infants are at greater risk of complications such as dehydration due to their developing immune systems. Preparing formula with hot water does not eliminate the toxin.

The a2MC recall follows a ByHeart infant formula recall announced last year as a result of potential contamination with a strain of Botulinum bacteria, which resulted in more than 50 infant illnesses, many of which required the children to be hospitalized.

Platinum Premium Infant Formula Recall

The recall affects 63,078 units of a2MC Platinum Premium 0–12 Month Infant Formula sold in 31.7 oz. tins. Of those units, 16,428 were sold to consumers through the company’s website, Amazon and Meijer stores as part of Operation Fly Formula. Importation rights expired on December 31, 2025, and the product was discontinued and removed from sale prior to the initiation of the recall.

The affected products include three batches of Platinum Premium USA label infant formula (0–12 months) milk-based powder with iron, including:

• Batch 2210269454 (use-by 7/15/2026)
• Batch 2210321712 (use-by 1/15/2027)
• Batch 2210324609 (use-by 1/21/2027)

Batch numbers and use-by dates can be found on the bottom of each tin.

Although no confirmed illnesses have been reported, consumers are advised not to use the affected products and to dispose of them immediately or return them to the place of purchase for a refund.

A health care provider should be contacted immediately if an infant develops symptoms. Adverse reactions can be reported to the FDA’s SmartHub safety intake portal or the MedWatch adverse event reporting system.

Consumers with questions can contact a2MC at 1-844-422-6455, Monday through Friday from 8 a.m. to 5 p.m. ET, or visit the company website.

Infant Formula Lawsuits

Bacterial contamination in infant formula has triggered a series of major recalls and lawsuits in recent years, raising serious concerns about manufacturing controls and the safety of powdered formula products given to newborns and infants.

In November 2025, ByHeart issued an infant formula recall after its products were linked to more than 50 cases of infant botulism. Following the illnesses, at least 19 families filed ByHeart infant formula recall lawsuits, alleging the manufacturer failed to prevent contaminated formula from reaching consumers.

The litigation follows earlier infant formula contamination concerns involving Abbott Laboratories. In 2023, a large recall was issued for Alimentum, EleCare and Similac formula products after reports linked the formulas to Salmonella and Cronobacter contamination. Those bacteria have been associated with severe infections in infants, including at least two reported deaths and hundreds of illnesses.

Subsequent investigations raised questions about whether Abbott ignored safety problems at its manufacturing facilities before the recalled formula was distributed nationwide. As a result, parents filed more than 100 Similac recall lawsuits, claiming their children suffered serious injuries after being fed contaminated infant formula.

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