ByHeart, a next-generation baby nutrition company, announced a voluntary recall of two batches of its Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) about an ongoing investigation into a nationwide outbreak of infant botulism.
The company emphasized that no ByHeart products have tested positive for contamination and that the recall is being conducted out of an abundance of caution. The FDA informed ByHeart on November 7, 2025, that 13 of the 83 reported infant botulism cases since August involved infants who had consumed ByHeart formula at some point.
However, the agency has not established a direct link between any infant formula and the illnesses. ByHeart Co-Founder and President Mia Funt said the company is acting proactively to “remove any potential risk from the market.”
Why It Matters
Infant botulism is a rare but potentially fatal illness caused by Clostridium botulinum spores colonizing an infant’s intestinal tract. While the FDA has not found a definitive connection between formula and the outbreak, the inclusion of ByHeart-fed infants among the reported cases has prompted heightened scrutiny.
The recall highlights the heightened sensitivity around infant formula safety following recent high-profile shortages and recalls. ByHeart’s swift action reflects the industry’s broader push for transparency and consumer trust amid ongoing regulatory oversight.
What To Know
The recall affects two specific batches of ByHeart’s Whole Nutrition Infant Formula: batch codes 251261P2 and 251131P2, both with a use-by date of December 1, 2026. The affected cans bear UPC 5004496800 and can be identified by the batch code and expiration date printed on the bottom.
ByHeart stated that neither its internal testing nor any regulatory agency has detected Clostridium botulinum spores or toxins in its products. The company maintains that its manufacturing processes meet or exceed global and U.S. safety standards.
The FDA is continuing its investigation into the 83 reported cases of infant botulism across the U.S. since August. While 13 of those infants had consumed ByHeart formula, the agency reiterated that there is no historical precedent of infant formula causing botulism, and no direct link has been identified.
Parents are advised to watch for signs, including constipation, poor feeding, droopy eyelids, a weak cry, low muscle tone, and respiratory issues. Immediate medical attention is recommended if symptoms appear.
Consumers who have the recalled formula should discontinue use and dispose of it. ByHeart is offering replacements and two additional cans at no cost for affected customers. Reports of illness can be submitted to the FDA via MedWatch.
What People Are Saying
Mia Funt, Co-Founder and President of ByHeart said: “The safety and well-being of every infant who uses our formula is our absolute highest priority. We take any potential safety concern extremely seriously and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
What Happens Next
The FDA will continue its investigation into the outbreak, and ByHeart has pledged to cooperate fully. The company is working with retailers and consumers to ensure the recalled batches are removed from circulation and replaced promptly.
