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