a2 Milk Company recalls infant formula batches due to cereulide contamination

The a2 Milk Company has voluntarily recalled 3 batches of its a2 Platinum Premium USA infant formula for infants aged 0 to 12 months after detecting cereulide, a heat-stable toxin associated with foodborne illness. The product was distributed exclusively in the United States.

Cereulide is produced by certain strains of Bacillus cereus and is not eliminated by standard preparation practices, including mixing formula with hot water. According to the company, ingestion of contaminated product can result in symptoms within 30 minutes to 6 hours, most commonly nausea and vomiting. These symptoms typically resolve within 24 hours; however, infants may be at higher risk for complications such as dehydration that require medical care.

“Although no confirmed incidents of illness or harm have been reported, affected batches must not be used,” the company stated.

Which products are affected?

The recall includes 3 batches of a2 Platinum Premium infant formula (milk-based powder with iron), packaged in 31.7-oz tins:

• Batch 2210269454 (use by July 15, 2026)
• Batch 2210321712 (use by January 15, 2027)
• Batch 2210324609 (use by January 21, 2027)

Batch numbers and expiration dates can be found on the bottom of each container. A total of 63,078 units were included in the affected batches, with approximately 16,428 units sold to consumers.

Distribution and regulatory context

The recalled product was distributed nationally through the company’s website, Amazon, and Meijer stores as part of Operation Fly Formula, a federal initiative to increase infant formula supply in the United States. Importation rights for the product expired on December 31, 2025, and the product had already been discontinued and removed from sale prior to the recall.

The recall was initiated after cereulide was detected during additional testing prompted by new guidance from New Zealand’s food regulatory authority. The company indicated that the probable source of contamination is an ingredient used in the product.

“This recall is being made with the knowledge of the US Food and Drug Administration,” the company noted.

Clinical considerations for physicians

Although no adverse events have been reported to date, clinicians should be aware of the potential for rapid-onset gastrointestinal symptoms in infants exposed to the affected formula. Monitoring for dehydration is particularly important given infants’ limited physiologic reserve.

Caregivers should be advised to discontinue use of the recalled product immediately and either dispose of it or return it to the place of purchase. If symptoms such as vomiting or nausea occur, prompt medical evaluation is recommended.

Adverse events can be reported to the US Food and Drug Administration through MedWatch.

Consumers with questions can contact the company directly via its customer support line at (844) 422-6455.

Reference

a2 Milk Company. a2 Platinum USA label infant formula recalled because of possible health risk. FDA. May 2, 2026. Accessed May 4, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/a2-platinum-usa-label-infant-formula-recalled-because-possible-health-risk?utm_medium=email&utm_source=govdelivery