Monday, May 4, 2026

Infant Formula Recalled Due to Potential Bacillus Toxin

The a2 Milk Company (“a2MC”),  a New Zealond company with a base in Boulder, CO, 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 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.

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.

From CIDRAP - https://www.cidrap.umn.edu/foodborne-disease/infant-formula-voluntarily-recalled-after-testing-positive-heat-stable-toxin
"The World Health Organization (WHO) says the symptoms of cereulide illness usually appear within 30 minutes to six hours after ingestion. It can include nausea, vomiting, and abdominal pain with risk of dehydration and electrolyte imbalance, which can be particularly severe in infants."
"From December 2016 to February 2026, at least 99 countries and territories have received infant formula products that were subject to recalls because of cereulide contamination. The WHO said in a March 13 press release that at least 144 suspected and confirmed cases were reported across 10 countries."
What is A2 milk?  From the company website (https://www.a2milk.com/truea2):
What is the difference between A1 and A2 protein types?
All cows originally produced only the A2 protein, but a natural change occurred over a thousand years ago, which caused the A1 protein to appear as a genetic variation. Today, most milk comes from cows that produce both A1 and A2 protein in their milk. But a2 Milk comes from cows that only produce A2 protein.
Why do people drink A2 milk?  Publication - Benefits of A2 Milk for Sports Nutrition, Health and Performance (Front Nutr. 2022) Jul  https://pmc.ncbi.nlm.nih.gov/articles/PMC9326461/ 
Abstract 
"Bovine milk is one of the best pre-and pro-workout sources for athletes owing to its rich nutritional content. Even though bovine milk consumption significantly benefits athletes' health and performance, many athletes cannot consume bovine milk since they struggle with gastrointestinal problems caused after milk consumption. Especially, the consumption of regular milk, which contains A1 β-casein, is associated with a variety of diseases ranging from gastrointestinal discomfort to ischemic heart diseases. The main reason behind this is related to β-casomorphine 7 (BCM-7), which is derived from A1 β-casein during the digestion of A1 milk. A1 β-casein is formed as a result of a point mutation in the position of 67th in the amino acid sequence A2 β-casein by changing proline to histidine. Therefore, this mutated form of β-casein in regular milk cannot easily be digested by the human-associated digestion enzymes. A2 milk, which includes A2 β-casein instead of A1 β-casein, is the best substitute for regular milk with the same nutritional content. This natural form of milk positively affects the athlete's health as well as performance without causing any gastrointestinal discomfort or more serious problems which are seen in the consumption of regular milk. In this review, A2 milk and its potential health effects in comparison to diseases related to A1 milk consumption are discussed."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/a2-platinum-usa-label-infant-formula-recalled-because-possible-health-risk
a2 Platinum USA Label Infant Formula Recalled Because of Possible Health Risk
Summary
Company Announcement Date:  May 02, 2026
FDA Publish Date:  May 02, 2026
Product Type:  Food & Beverages  Infant Formula & Foods
Reason for Announcement:  Presence of cereulide toxin produced by some strains of the bacterium Bacillus cereus
Company Name:  A2 Milk Company
Brand Name:   a2
Product Description:  a2 Platinum Premium Infant Formula 0-12 months USA label

Company Announcement

Boulder, CO – May 2, 2026 – 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.

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
Product Name Packaging Format Batch Number Use By Date
a2 Platinium Premium infant formula 0-12 months Milk-based powder with Iron 31.7oz tin 2210269454 7/15/2026
31.7oz tin 2210324609 1/21/2027
31.7oz tin 2210321712 1/15/2027

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 Formula. Importation rights expired on December 31st, 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:


CIDRAP
https://www.cidrap.umn.edu/foodborne-disease/infant-formula-voluntarily-recalled-after-testing-positive-heat-stable-toxin
Infant formula voluntarily recalled after testing positive for heat-stable toxin
News brief Today at 2:27 p.m.
Sarah Boden
Topics Foodborne Disease
Infant formula sold on Amazon and at Meijer stores has been voluntarily recalled by the New Zealand-based a2 Milk Company.

Though the Food and Drug Administration (FDA) reports "no confirmed incidents of illness or harm have been reported," the agency wants people to dispose of imported a2 Platinum Premium USA label infant formula 0-12 months with the following batch numbers: 2210269454, 2210324609, 2210321712.

The recall was reportedly initiated after cereulide, a toxin, was detected through additional testing in accordance with guidance recently issued by New Zealand's food regulatory authority.

"The recall is isolated to the USA label Product, which has a different formulation and relevant ingredient to the English label a2 Platinum infant formula sold in Australia, New Zealand, South Korea, Vietnam and through cross border channels into China,” the company said in a press release.

The a2 formula was imported during Operation Fly Formula, according to the company and FDA. The 2022 initiative used government planes and personnel to accelerate shipments of infant formula during a national shortage in the United States. The FDA reports that a total of 16,428 affected tins were sold and that the product was discontinued prior to the recall.

Recent rash of cereulide contamination
Cereulide is produced by certain strains of the bacterium Bacillus cereus. The toxin is heat-stable so boiling water will not destroy it.

The World Health Organization (WHO) says the symptoms of cereulide illness usually appear within 30 minutes to six hours after ingestion. It can include nausea, vomiting, and abdominal pain with risk of dehydration and electrolyte imbalance, which can be particularly severe in infants.

From December 2016 to February 2026, at least 99 countries and territories have received infant formula products that were subject to recalls because of cereulide contamination. The WHO said in a March 13 press release that at least 144 suspected and confirmed cases were reported across 10 countries.


"The full root cause analysis and complete traceability of all affected batches remains under investigation," said the international health agency.


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