A2 Infant Formula Recalled Due to Cereulide Contamination

Boulder, Colo. — The a2 Milk Company, Auckland, New Zealand, has voluntarily recalled three batches of its imported a2 Platinum Premium USA label infant formula for 0-12 months due to the presence of cereulide. The product was distributed nationally and sold only in the United States.

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, said the U.S. Food and Drug Administration (FDA).

Symptoms typically develop within 30 minutes to six hours of ingestion and most often involve gastrointestinal symptoms such as nausea and vomiting. Infants are at greater risk due to their developing immune systems and can experience complications, such as dehydration, which require medical care, said FDA.

For a list of recalled products, click here. The batch number and “use by” date are found on the bottom of each tin.

The product was distributed nationally through a2’s website, Amazon and Meijer stores as part of Operation Fly Formula, a 2022 government initiative to combat a nationwide infant formula shortage. The three recalled batches contain 63,078 units, of which an estimated 16,428 were sold to consumers, according to the company.

Importation rights for the product expired on Dec. 31, 2025, and the product was discontinued and removed from sale before the recall.

No confirmed incidents of illness have been reported.

The recall was initiated by a2 after cereulide was detected through product testing 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, the company said.

Consumers who have purchased the product are recommended to discontinue use and dispose of it immediately or return to the 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 issue through SmartHub, or
• Complete and submit a Medwatch report at www.fda.gov/medwatch/report.htm, or by mail or fax. 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 through Friday, 8 a.m. to 5 p.m. ET, or through its website, a2platinum.com.