First Published Date: December 23, 2025

To our ByHeart customers, 

We want to take a moment to update you on the recent recall of ByHeart products and to share what we have learned thus far, and what we’re focused on going forward as we continue to seek to understand how this happened and prevent it from happening again to any formula feeding parent. 

First and most importantly: we are deeply sorry for the distress and challenges this event has caused our customers, our partners, our retailers, and everyone connected to the ByHeart brand. We are fully committed to finding evidence-based information and answers to restore trust and confidence not only in ByHeart but also in infant formula. We are learning through this unprecedented moment and we are grateful for your patience. 

What we know today

Immediately upon receiving the initial notice from FDA of an investigation into an outbreak of infant botulism linked to ByHeart formula on November 7, ByHeart voluntarily recalled two batches of product connected to the initial cases on November 8. We then partnered with IEH Laboratories & Consulting Group, a respected leader in Food Safety testing, to conduct testing on unopened cans of ByHeart products. We have received positive test results for Clostridium botulinum in six of 36 samples of finished product we have tested. These six samples were taken from two batches (Batch 251261P2 and Batch 251131P2), and IEH has confirmed these results as conclusive positives through whole genome sequencing. These two batches were in the initial product recall on November 8.  

All batches of ByHeart infant formula, and all products including cans and Anywhere Pack sticks nationwide, were recalled as of November 11, 2025. ByHeart also notified retailer partners and confirmed that communication was sent to stores.

Until we can confirm a root cause, we are operating as though every aspect of our operations requires careful consideration of its potential role in product contamination. 

Steps we’ve taken  

We have recalled and paused all production of our ByHeart products and directed our resources toward implementing a rigorous and ongoing audit of every step of our supply chain, from packaging and transportation through to ingredient suppliers. This includes thorough testing of everything in our ecosystem from finished goods and raw ingredients to primary packaging and environmental swabs from across the manufacturing process. We have enlisted world-class Food Safety and Clostridium botulinum experts to tour our facilities, review data collection, and help identify all possible entry points. 

Additional testing across ingredients, manufacturing processes, and handling procedures remains underway and we continue to cooperate fully with regulatory agencies.

ByHeart is providing a full refund for all products purchased on ByHeart.com on or after August 1, 2025. Please call us at 866-201-9069 and our team will assist you. For customers who purchased ByHeart products at retail stores, that retailer will handle your refund. We encourage customers to contact retailers directly to process their refunds for ByHeart infant formula.

What we are committed to next 

Evidence and innovation have always been in ByHeart’s DNA, and we are committed to getting to the answers and using them to help strengthen quality and safety practices for the benefit of every family. We are also dedicated to restoring trust in our facilities, our process, and the people who are dedicated to improving the lives of infants and their families through transparency, quality, and accountability. 

We promise to keep you informed with timely updates as we learn more and make progress in our investigations. If or when we find a root cause, we will be diligent in outlining corrective actions. 

We are actively partnering with industry-leading Clostridium botulinum experts to not only support and enrich our ongoing investigations with their expertise, oversight and perspectives, but also aid in broader understanding of Clostridium botulinum detection and testing best practices. 

We appreciate your feedback and questions. Your voices matter to us, and together we can create safer infant nutrition for all families.