First Published Date: November 19, 2025

To families everywhere,

Our core mission has always been protecting babies. After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test cans of ByHeart formula, and conducted a nationwide recall. We have just learned that those tests identified Clostridium botulinum in some samples of ByHeart formula. We immediately notified the FDA of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.

We continue to urge parents and caregivers to stop using ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.

We have been working in cooperation with the FDA, and we are investigating every facet of our process – from ingredient-sourcing to our manufacturing process and facilities, packaging, transportation, everything. 

We do not yet know the root cause, but we are committed to finding the answers. We are doing everything we can to ensure this investigation reveals solutions and aids in understanding cases of infant botulism broadly. That’s what parents, the medical community, and you deserve. 

We know families are looking for clarity and stronger safeguards, and we are committed to the following: 

• On-going analysis of our entire ByHeart production and safety protocols, including an independent expert review of our equipment, materials, and procedures, and our entire supply chain from sourcing to retail. 
• Improving transparency for families by updating our Safety and Education Hub with answers to your questions and expanding customer service to reduce wait times and offer better support. We will update the website with any new information as soon as we learn more. 
• Until now, this bacterium was not among the pathogens routinely tested for across the industry, despite thousands of safety tests conducted by all manufacturers. We are working with the FDA to understand how Clostridium botulinum entered the food supply and to be part of the solution by advancing testing standards and safeguards to ensure the highest level of safety for families.

We’ve brought together global experts in microbiology, food safety, and this specific pathogen as part of this goal and invite collaboration from those committed to using this unprecedented moment to make our ByHeart processes and the industry at-large safer.

ByHeart has grown because parents trusted us, and we are committed to rebuilding your trust. We started this brand as two parents, wanting to do better for babies, and we have never been more committed to that mission.

With love,

Mia & Ron