a2 Milk Company (“a2MC”) has recalled three specific batches of imported a2 Platinum Premium USA labeled infant formula for ages 0-12 months due to the presence of cereulide. This product is sold only in the United States.
Cereulid is a thermostable toxin produced by some strains of the bacteria Bacillus cereus. Illness is caused by eating food contaminated with toxins, and cooking baby formula in hot water does not remove the toxins.
Symptoms generally occur within 30 minutes to 6 hours after ingestion, with gastrointestinal symptoms such as nausea and vomiting appearing most often and usually disappearing on their own within 24 hours. Infants are at greater risk due to their developing immune systems and may experience complications that require medical attention, such as dehydration.
No confirmed cases of illness or damage have been reported, but affected batches should not be used. Because of the long shelf life, there are concerns that consumers may store the product at home.
The recalled product can be identified by the following information for the 31.7-ounce can:
Batch number 2210269454, expiration date July 15, 2026
Batch number 2210324609 with an expiration date of January 21, 2027
Batch number 2210321712, expiration date January 15, 2027
The batch number and “use by” (expiration) date are marked on the bottom of each tin.
The product was distributed nationwide through the a2MC website, Amazon and Meijer stores as part of Operation Fly Formula. Import rights expired on December 31, 2025, and the product was discontinued and removed from sale before the recall began. The total number of units across the three batches was 63,078, of which approximately 16,428 units were sold to consumers.
The recall was initiated by a2MC after cereulide was detected through further testing of the product conducted under new guidance issued by the New Zealand Food Regulatory Authority. The source of cereulide is believed to be an ingredient in the product.
This recall is based on the knowledge of the U.S. Food and Drug Administration (FDA).
Consumers who have purchased the product in question are requested to immediately stop using the product, discard it immediately, or return it to the place of purchase for a refund. If your baby develops any of the symptoms described above, contact your health care provider right away. To report a medical condition or side effect to FDA:
- Report a product issue via SmartHub or
- Complete and submit your Medwatch report online at www.fda.gov/medwatch/report.htm or by regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then mail the completed pre-addressed form to the address or fax it to 1-800-FDA-0178.
The batch number and “use by” (expiration) date are marked on the bottom of each tin (see example below with product image).
The batch number and “use by” (expiration) date are marked on the bottom of each tin (see example below with product image).
The product was distributed nationwide through the a2MC website, Amazon, and Meijer stores as part of Operation Fly Formula(1). Import rights expired on December 31, 2025, and the product was discontinued and removed from sale before the recall began. The total number of units across the three batches was 63,078, of which approximately 16,428 units were sold to consumers.
