a2 Platinum USA Label Infant Formula Recalled Because of Possible Health Risk

The a2 Milk Company (“a2MC”) has voluntarily recalled three specific batches of its imported a2 Platinum Premium USA label infant formula 0-12 months (“Product”) due to the presence of cereulide. The Product is sold only in the United States.

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a2 Platinum USA Label Infant Formula Recalled Because of Possible Health Risk

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 due to their developing immune systems and can experience complications such as dehydration which require medical care.

Product Information

The batch number and “Use By” (expiration) date are found on the bottom of each tin (refer to example below, together with image of product).

The Product was distributed nationally through a2MC’s website, Amazon and Meijer stores as part of Operation Fly Formula¹. Importation rights expired on December 31^st, 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.

Although no confirmed incidents of illness or harm have been reported, affected batches must not be used.

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.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Consumers who have purchased the Product are recommended to discontinue use of the Product 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 1-800-FDA-0178

Consumers with questions may contact a2MC at 1-844-422-6455, Monday-Friday, 8am to 5pm Eastern time zone, or contact us through our website on a2platinum.com.

¹ under U.S. Food and Drug Administration enforcement discretion.

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