ByHeart says “pooh-pooh” – Public Health has it wrong, it was not us that sickened now 15 with Botulism

Here it is directly from ByHeart’s website after they spent the day on Zoom with consumer groups trying to convince them the of “alternative facts.”

DATE: NOVEMBER 10, 2025

An Open Letter to the U.S. Food & Drug Administration

Together with the FDA, CDC and other state public health agencies, we share a common goal: protecting babies and giving families the clear, actionable information they deserve. We believe that collaboration, transparency, and decisive action are essential to achieving that goal.

We’re writing to invite immediate collaboration on the next critical step of the comprehensive investigation into infant botulism and understand the potential causes of the broader 83 cases identified by the FDA.   

We believe it is in the best interest of parents, caregivers, and public health for the FDA, CDC and other state public health agencies to conduct testing of unopened cans from the recalled batches at our facility. Testing unopened cans will provide reliable evidence that will help bring clarity to families who are understandably concerned, as currently, no U.S. or imported formula is required to be tested for Clostridium botulinum.

As the FDA and CDPH continue their investigations, we stand ready to partner with them at every step, providing full access to our facilities and unopened cans, without restriction. Our shared priority should be resolving uncertainty quickly, identifying the true cause of these cases, and protecting the health and well‑being of every baby.

When we learned of this unprecedented spike in 83 infant botulism cases from FDA, we recognized the need for immediate action. The FDA alerted us that in 13 cases, babies had consumed ByHeart formula so we acted as any parents would: urgently, decisively, and with the safety of every child in mind. We voluntarily recalled the relevant batches within 24 hours, and launched our own independent testing with a third‑party laboratory using food safety best practices.

As parents, and as a business deeply committed to safety and transparency, we know how many families have entrusted us to feed their babies — and we never take that responsibility lightly.

Mia, Ron & The Team at ByHeart

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FIRST PUBLISHED DATE: NOVEMBER 9, 2025

An Update For Our ByHeart Family,

Yesterday, only hours after receiving the news ourselves, we shared an update about the FDA’s broader investigation into infant botulism among 83 babies in the US and the 13 cases involving babies who drank ByHeart formula. 

As parents, and as a team deeply committed to safety and transparency, we will continue to provide you with clear, actionable information. As such, we have created this page to continue to update you with any new details we have to share.

We know how much trust it takes to feed your baby, and we don’t take that lightly. We want you to know that we’re in it with you every step of the way.

WHAT WE KNOW

Today, we were made aware by the California Department of Public Health (CDPH) that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. We are treating the CDPH’s test result very seriously.

However, testing from a previously-opened can lacks scientific basis to establish causation between the product and illness. We know that Clostridium botulinum is a bacteria that exists naturally in the environment—in places like soil, dust, and even vegetables—meaning that an opened can can be contaminated in multiple ways. 

Currently global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum, and no U.S. or global infant formula company tests for Clostridium botulinum.

WHAT ARE WE DOING

Because we are treating the CDPH’s results with the utmost seriousness, we are conducting testing, with a third party independent testing laboratory, of the two recalled batches of our formula using food safety testing best practices, to provide you results that we all can feel confident in. 

From the very beginning, we have acted quickly and decisively to remove any potential risk— immediately voluntarily recalling the relevant batches of our formula that the FDA told us were consumed by infants in their investigation. We want to remind you to dispose of any cans with the recalled batch codes and to reach out to our Parent Experience team for support. They can help you replace your formula at no cost. 

OUR COMMITMENT TO YOU

We will continue to share updated information directly and on our website and Instagram. Also, our Parent Experience team is always here to support you with anything you need, and can be reached at hello@byheart.com.

We, along with our own families, friends, and team members, use ByHeart every day—and continue to do so. We are committed to our product, our safety systems and the people behind them, and to all of you.

With love,

Mia & Ron, ByHeart Co-Founders

BTW, Mia & Ron, here is an email from one of your customers:

My infant daughter was diagnosed with infantile botulism and spent 2 weeks in the ICU, followed by a month on a feeding tube. At the time, we had no confirmed source. We have now received a recall notice for ByHeart formula, which she was consuming. Our expiration dates match the recalled product.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/byheart-says-pooh-pooh-public-health-has-it-wrong-it-was-not-us-that-sickened-now-15-with-botulism/