FDA expands urgent baby formula recall to all products made by one manufacturer | Official Website of Louis Velazquez, entrepreneur, finance guy and tech innovator

This story has been updated to reflect the FDA’s November 11, 2025, announcement.

The baby formula market is dominated by a handful of companies, including Abbott Labs, Mead Johnson, and Nestle.

Together, these companies account for more than 80% of the infant formula market in the U.S., according to data compiled by the Federal Trade Commission (FTC).

When a company that makes products for the most vulnerable Americans faces a product recall, whether it’s a car seat, crib, or stroller, parents are justifiably worried.

Now, a company that has been selling baby formula for less than five years and accounts for just 1% of the market is facing a big problem no company wants.

ByHeart, which launched in 2021, is recalling its “Whole Nutrition Infant Formula” because some of the product may be contaminated with Clostridium botulinum, the bacteria that cause infant botulism.

ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that have been reported nationwide since August 2025. Of these cases, the FDA noted that 13 infants received ByHeart formula at some point. The FDA issued a voluntary recall for the ByHeart formula on November 8, 2025.

The company announced on November 11 that it is recalling all of its products and has given the DDA complete and unrestricted access to all of of the company’s facilities and products for their investigation.

“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” Co-Founder and President of ByHeart Mia Funt said. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve,” Funt wrote in the updated FDA announcement.

A new baby formula manufacturer is facing a recall.

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All ByHeart formula now being recalled

While all ByHeart baby formula products are now being recalled, the original recall only affected the following products:

Name: ByHeart Whole Nutrition Infant Formula
Batch Code: 251261P2
UPC: 5004496800
Use by date: December 1, 2025
Sizes: Whole Nutrition Infant formula 24 oz cans and 0.6oz packets
Where the product was sold: The potentially contaminated formula was sold in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

ByHeart baby formula recall details

The company and the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating the source of contamination.

The illness in question is infant botulism, caused when spores of the bacterium Clostridium botulinum germinate in a baby’s large intestine and produce toxins. Symptoms may include weak muscle tone, difficulty feeding, loss of head control, swallowing difficulties and respiratory compromise.

Symptoms may take several weeks to appear, according to the Centers for Disease Control (CDC).

ByHeart has emphasized that, so far, no toxins have been confirmed in its product, but the company is issuing a recall “out of an abundance of caution.” Meanwhile, the FDA has said it is collecting leftover product for testing and working to determine the contamination point.

Consumer and supply‑chain implications of recalls

For parents and caregivers, the immediate directive is clear. Check container lot codes for the affected numbers; if you purchased those lots, stop using the product, document the lot number, return or dispose of the container, and clean any surfaces that contacted the formula.

Seek medical attention if any symptoms of botulism poisoning appear.

From a business and industry vantage point, the episode rolls into broader concerns around the U.S. infant‑formula market, since supplies are highly concentrated, with just a few manufacturers servicing most of the market.

This means even small‑scale disruption can have broad ripple effects. For example, preceding this event, the U.S. experienced major formula outages when Abbott Laboratories recalled dozens of lots in February 2022 due to possible Cronobacter sakazakii contamination at a key facility, according to TechTarget, which has written about how the FDA is working to reduce risks of contamination.

Although ByHeart itself is a smaller player, the recall may nevertheless prompt greater scrutiny of the entire infant‑nutrition supply chain — including manufacturing safeguards, import controls, lot‑tracking systems, and regulatory inspections. The FDA had already expanded its oversight after the prior recall emergency, according to the FDA website.

Risks for manufacturers and retailers involved in product recalls

For ByHeart, the recall poses reputational risk, potential liability (though no link has yet been legally established), and operational disruption. If additional contamination is confirmed or the investigation finds systemic issues, the financial and regulatory consequences could widen.

For retailers and supply-chain partners, the recall may trigger product-return and disposal costs, potential markdowns, and increased audit and logistics burdens.

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Even as the product in question represented only about 1% of the market, public‑health concerns could prompt substitution or brand‑switching behavior among cautious caregivers.

What may happen after ByHeart baby formula recall:

The FDA or CDC may link the contamination definitively to the product or the manufacturing environment, which could lead to further enforcement actions or a recall expansion.
Given the hospitalizations, there is a risk of a class-action lawsuit against the manufacturer, although no deaths have been reported.

This recall serves as a reminder that even relatively small players in tightly regulated consumer‑health categories can trigger major disruptions — especially when the product addresses the most vulnerable population, infants.

To report an illness or adverse event, consumers can:

Call an FDA Consumer Complaint Coordinator to speak directly to a person.
Complete an electronic Voluntary MedWatch form online.
Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

ByHeart customers can contact the company at [email protected], visit byheart.com External Link Disclaimer, or call 1 (833) 429-4327.