Baby Formula Recall: Warning Issued for 60K Cans Used to Combat Shortage

The a2 Milk Company is voluntarily recalling over 60,000 cans of baby formula that were brought into the United States under an initiative by former President Joe Biden to combat a formula shortage. The formula, which hasn’t expired, could make babies sick, and parents are being warned to throw out the affected batches.

A2 formula is produced in New Zealand and was sold in the United States through a2MC’s website, Amazon, and Meijer stores as part of Operation Fly Formula. Launched by the Biden administration in 2022 at the height of a nationwide baby formula shortage, the government airlifted formula into the United States from other countries that met FDA safety standards. The goal was to bypass shipping delays to get the product to parents quickly.

The recall affects three batches of a2 Platinum Premium USA infant formula, which were distributed nationally as part of the 2022 initiative. The importation rights for the formula expired on December 31, and the product was discontinued before the recall was initiated.

a2 Platinum Premium Formula Recall Explained

On May 2, the a2 Milk Company voluntarily recalled three specific batches of its imported a2 Platinum Premium USA label infant formula, intended for babies ages 0 to 12 months, after additional testing detected cereulide, according to the U.S. Food and Drug Administration (FDA). No illnesses have been reported because of the formula, but health officials are urging parents to stop using the affected cans immediately.

The affected product was sold in 31.7‑ounce tins with the following batch numbers and "use by" dates:

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

In total, 63,078 cans were included across the three recalled batches, with an estimated 16,428 units sold to consumers, the FDA said. Importation rights for the formula expired on December 31, 2025, and the product had already been discontinued before the recall was formally announced.

What Is Cereulide?

Cereulide is a heat‑stable toxin produced by certain strains of the bacterium Bacillus cereus. It’s not contagious, and illness only occurs when a person ingests the toxin. Since some babies may rely entirely on formula, the World Health Organization (WHO) noted that repeated feedings could increase the amount of toxin the baby consumes and dehydrate babies even more, thereby worsening illness.

“Where there is limited access to health care and where there may be delays in care seeking, rapid dehydration and electrolyte imbalance in infants may be fatal,” the WHO said.

Symptoms typically begin within 30 minutes to six hours after ingestion and most often include nausea and vomiting. While symptoms usually resolve within 24 hours, infants are considered at higher risk due to their developing immune systems and the danger of dehydration.

The FDA said cereulide was detected during additional testing conducted in response to new guidance issued by New Zealand's food regulatory authority, and the probable source was traced to an ingredient used in the formula.

Can Baby Brezza Formula Maker Kill Cereulide?

Unlike many foodborne bacteria, cereulide is not destroyed by boiling, reheating, or hot water, which is why federal officials say affected formula should not be used under any circumstances. So, even if a parent uses a Baby Brezza formula maker, which heats water before adding it to the bottle, it won’t kill the bacteria.

Parents should not attempt to fix or treat recalled formula in any way. Instead, affected cans should be discarded, and if the formula has been put into a Baby Brezza or other formula maker, parents should thoroughly clean the machine before using it again.

What Kind of Water to Use for Baby Formula

While the FDA recall notice focuses on contamination risk rather than preparation methods, pediatric guidance recommends preparing powdered infant formula with safe, clean drinking water that meets local public health standards. For newborns, pediatricians recommend boiling water and letting it cool before using it in a bottle. Boiling the water can kill some bacteria, which is why it’s recommended for newborns.

Parents using tap water in the U.S. are typically advised to check whether boiling is recommended in their area, particularly during boil‑water advisories. In households with older plumbing or well water, pediatricians often recommend filtering or separately testing the water. Any parent who thinks the tap water in their home is unsafe should use bottled water to prepare baby bottles until officials say it’s safe to drink, the Centers for Disease Control and Prevention (CDC) said. Distilled water can also be used.

"In general, especially for infants under three months or those with underlying health issues, erring on the side of caution makes sense," Dr. Krupa Playforth, MD, FAAP, told Babylist.

Shelf Life for Baby Formula

Unopened formula has a very long shelf life, and it’s not uncommon for parents to stock up to ensure they have it when they need it, especially if their baby is only drinking formula. For example, one of the impacted batches won’t expire until January 2027, but was manufactured in July 2025.

The shelf life of premade formula, which comes in liquid form, is typically much shorter, lasting less than a year unopened.

Once opened, formula should be used within the time frame specified by the manufacturer and stored exactly as directed. Any formula that smells unusual, clumps excessively, or appears discolored should not be used-even if it is not part of a recall.

The FDA emphasized that the batch number and expiration date for the recalled a2 Platinum formula are located on the bottom of each tin.

When Does a Baby Stop Drinking Formula?

The recalled a2 Platinum Premium product is intended for infants up to 12 months of age, according to the FDA labeling.

In general pediatric practice, most babies transition off infant formula around their first birthday, at which point pediatricians may recommend whole milk or alternative nutrition depending on a child's health and dietary needs. At this point, babies start to get most of their nutrition from solid foods, which they begin eating around six months of age. Parents are advised to consult their pediatrician before making changes.

While the agency stressed that no illnesses have been reported in connection with the recall, parents are advised to monitor their child if they’ve consumed it and to seek medical care if their child develops any symptoms.

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This story was originally published May 6, 2026 at 5:26 PM.