Infant formula recalled because of contamination with cereulide

The a2 Milk Company (“a2MC”) has voluntarily recalled three specific batches of its imported a2 Platinum Premium USA label infant formula 0-12 months because it is contaminated with cereulide.

Cereulide is a heat-stable toxin produced by some strains of the bacterium Bacillus cereus. Illness occurs through the consumption of food contaminated with the toxin and preparing formula with hot water does not eliminate it.

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. Infants are at greater risk because of their developing immune systems and can experience complications, such as dehydration, which require medical care.

The batch number and “Use By” dates for the recalled product are as follows and are found on the bottom of each tin. a2 Platinium Premium infant formula 0-12 months Milk-based powder with Iron sold in 31.7 ounce cans with any of the following batch numbers and use-by date combinations:

batch 2210269454 use-by 7/15/2026

batch 2210324609 use-by 1/21/2027

batch 2210321712 use-by 1/15/2027

The Product was distributed nationally through a2MC’s website, Amazon and Meijer stores as part of Operation Fly Formula. Importation rights expired on Dec. 31, 2025, and the product has been discontinued and removed from sale prior to the initiation of the recall. The total number of units in the three batches is 63,078 of which an estimated 16,428 units were sold to consumers.

No confirmed incidents of illness or harm have been reported.

The recall was initiated by a2MC after cereulide was detected through additional testing of the product conducted in response to new guidance issued by New Zealand’s food regulatory authority. The probable source of cereulide is an ingredient in the product.

Consumers who have purchased the product are recommended to discontinue use of it and dispose of it immediately or return to their place of purchase for a refund. If your infant is experiencing symptoms described above, contact your health care provider immediately. To report an illness or adverse event to the FDA, you can:

• Report a Product Problem through SmartHub, or
• Complete and submit a Medwatch report Online at www.fda.gov/medwatch/report.htm, or by Regular Mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178