ByHeart Infant Formula Recalled After Botulism Outbreak

Powdered milk linked to dozens of infant illnesses across 19 states

Apr. 11, 2026 at 1:07am

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A ghostly, translucent X-ray photograph revealing the internal molecular structure of an infant formula can, with glowing lines defining the powdered milk contents against a dark background, conceptually illustrating the hidden contamination at the center of this public health crisis.An X-ray view of the contaminated powdered milk at the heart of the ByHeart infant formula recall, exposing the unseen dangers lurking within.NYC Today

The U.S. Food and Drug Administration has discovered that powdered whole milk used in ByHeart infant formula may be linked to a troubling outbreak of botulism, resulting in dozens of infants falling ill across 19 states. Investigations are ongoing to pinpoint the exact source of the contamination.

Why it matters

This alarming situation raises serious concerns about the safety protocols in place for infant formula production and the responsibilities of manufacturers in ensuring the well-being of vulnerable consumers. The extent of the ByHeart outbreak is unprecedented, highlighting the need for stricter industry-wide testing requirements.

The details

The FDA found the type of bacteria responsible for causing botulism in two samples associated with ByHeart's formula, including an unopened container that matched a sample taken from an ill infant. Further analysis revealed that a sample of the whole milk powder supplied to ByHeart also contained the harmful bacteria. ByHeart has recalled all of its products, but the company and officials have not yet disclosed the identity of the milk supplier.

  • In November 2023, California health officials noticed a spike in infant botulism cases linked to ByHeart products.
  • In December 2023, the U.S. Centers for Disease Control and Prevention reported no additional cases since mid-December.
  • ByHeart launched its formula business in March 2022.

The players

ByHeart

A New York-based infant formula company that was marketing its product as a close alternative to human breast milk, featuring "organic, grass-fed whole milk" as the main ingredient.

Dr. Devon Kuehn

ByHeart's chief scientific and medical officer, who commented on the situation, describing it as a pivotal moment for the company.

U.S. Food and Drug Administration (FDA)

The federal agency that conducted tests and investigations into the contamination of ByHeart's infant formula.

Bill Marler

A food safety attorney representing numerous families affected by the ByHeart botulism outbreak, who asserted that the company is legally and morally responsible despite the contamination originating from a supplier.

Sarah Sorscher

The director of regulatory affairs at the Center for Science in the Public Interest, who emphasized the need for mandatory testing requirements across the infant formula industry.

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What they’re saying

“We are focused on identifying the root cause and understand our responsibility to implement what we've learned to foster a safer future for both ByHeart and the infant formula market.”

— Dr. Devon Kuehn, Chief Scientific and Medical Officer, ByHeart

“Pointing fingers at the dried powder doesn't absolve ByHeart of its legal or moral obligations.”

— Bill Marler, Food Safety Attorney

“The FDA has yet to announce a comprehensive testing plan, which is something advocates want to see implemented.”

— Sarah Sorscher, Director of Regulatory Affairs, Center for Science in the Public Interest

What’s next

The FDA and ByHeart continue to investigate the root cause of the botulism contamination, and the agency has not yet announced a comprehensive testing plan for the infant formula industry.

The takeaway

This unprecedented botulism outbreak linked to ByHeart's infant formula highlights the urgent need for stricter safety regulations and mandatory testing requirements across the industry to protect vulnerable infants and restore public trust in the safety of these critical products.