On February 26, 2026, the CDC and FDA announced that the infant botulism outbreak has ended, with no new cases reported since December. We are grateful to hear this news, but there’s still much more to do. We take our responsibility to ByHeart families incredibly seriously, and we are deeply sorry for the impact this outbreak has had on our community. 

FDA’s investigation into the root cause of the contamination is still ongoing, and we continue to cooperate fully. The FDA continues to share significant progress. In its February 26th update, the FDA announced that whole genome sequencing (WGS) analysis confirmed two new samples from one lot of Organic Whole Milk Powder, collected by FDA from a supplier, match a previously identified ByHeart formula sample and a sample from a sick infant. More detail on FDA’s findings can be found here. 

As we await further developments in the investigation, we are working in parallel to take what we’ve learned from the investigation to develop a comprehensive action plan to prevent this from happening again. This plan includes implementing new, enhanced safety and testing protocols for ingredients and finished products, identifying new suppliers for certain ingredients, enhancing supplier standards, and establishing an independent Food Safety Council to validate our protocols and help anticipate future risks. 

The CDC and FDA update marks the end of the outbreak, but for us, our work to develop new standards, going further beyond industry standards to pioneer a new model for safety, is not over. We are moving forward with the same determination that built ByHeart, because that is what parents deserve. We will continue to be transparent and will share more information on our enhanced safety measures as we move forward.