a2 Milk Company Ltd. (ACOPF,A2M.AX), a dairy company, announced a recall of select infant milk formula, manufactured by Synlait Milk Limited and sold only in the United States, citing the presence of cereulide.
The recall involves three batches of a2 Platinum USA label infant milk formula, comprising 63,078 tins in total with an estimated 16,428 tins sold to consumers. These were distributed through a2MC's website, Amazon and Meijer stores as part of Operation Fly Formula, Under U.S. Food and Drug Administration enforcement discretion.
The company noted that the importation rights expired on December 31, 2025, and the recalled product had been discontinued and removed from sale prior to the initiation of the recall.
The recall was initiated after cereulide was detected through additional testing of the product following the release of New Zealand Ministry for Primary Industries or MPI's industry update and expectations for managing cereulide on April 15 with application retrospectively for New Zealand infant formula manufacturers.
As per the company, the probable source of cereulide is an ingredient in the product.
If cereulide affects consumers, 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.
However, the company has not received any reports of confirmed incidents of infant illness or harm.
The USA label Product has 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.
all a2 Platinum product sold outside the United States is unaffected.
The company added that the recall is not expected to impact its financial results. Total USA IMF sales accounted for around 0.1% of the company's total sales revenue in the first half.
a2MC said it is contacting FDA, and has released guidance to its U.S. consumers about actions they should take if they have purchased the product.
In Australia, the shares closed Monday's regular trading at A$6.55, down 9.90%.
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