Urgent Update Regarding Our Voluntary Recall
To the valued members of our healthcare community: In response to a broader FDA investigation of infant botulism in babies across the U.S, we are expanding our voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs™ nationwide. This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin.
At this moment, the most important thing for you to know is that all ByHeart product must be discarded, including all in-office samples.
The safety and wellbeing of every infant remains our top priority. For the most current information, please visit the link below.
A clinical trial 25 years in the making.
ByHeart ran one of the largest clinical trials for an infant formula brand in the US in 25 years, published in the Journal of Pediatric Gastroenterology and Nutrition. We included 311 healthy, term infants and assigned them to either ByHeart formula, a leading commercial formula, or a human milk-fed reference group. We were also the first new brand to add a comparison to human milk.
Our 6-month randomized, double blind, multi-center trial exceeded FDA requirements with a systems biology approach.
Less Spit-up*
Parent-reported number of spit-ups per day
*vs. a leading infant formula
Softer Stools*
Parent-reported stool consistency
*vs. a leading infant formula
Higher Energetic Efficiency*
Efficiency of growth for weight
*vs. a leading infant formula
Higher Serum Essential Amino Acids*
Concentration of essential and conditionally essential amino acids**
*vs. a leading infant formula
**Based on a subgroup (N=74) of per-protocol infants without any complementary food intake.
