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