Important Information Regarding Our Voluntary Recall
To the valued members of our healthcare community:
Our November 2025 recall remains in place, and we continue to cooperate fully with FDA. All batches of ByHeart Whole Nutrition Infant Formula, including cans and Anywhere Pack sticks nationwide, are recalled. We urge parents and caregivers to stop using ByHeart formula immediately, monitor their child for symptoms of infant botulism, and seek medical care immediately if symptoms develop. Healthcare professionals should discard all in-office samples.
The safety and wellbeing of every infant remains our top priority. We have developed a comprehensive plan that reaffirms our commitment to safety and quality and outlines our corrective actions – from new testing methods to enhanced oversight.
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.
