ByHeart, a company specializing in baby nutrition, has voluntarily recalled two batches of its Whole Nutrition Infant Formula after being notified by the U.S. Food and Drug Administration (FDA) about an ongoing investigation into a recent outbreak of infant botulism.
Infant botulism is a rare but serious illness caused when Clostridium botulinum spores are ingested and produce toxins in the intestines of infants. Symptoms can include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, weak cry, and respiratory issues.
The FDA is currently investigating cases of infant botulism among babies in the United States. According to information provided to ByHeart by the FDA on November 7, 2025, there have been an estimated 83 cases nationwide since August 2025. Of these cases, 13 infants had received ByHeart formula at some point. The FDA has not established any direct link between infant formula and these cases and notes that there is no historical precedent for infant formula causing infant botulism. Botulism more commonly occurs from environmental sources such as soil or dust rather than dairy products or formula.
ByHeart stated that all its products adhere to global and U.S. safety standards and that none have tested positive for contaminants.
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."
The recall affects two batches with codes 251261P2 and 251131P2 (use by December 1, 2026; UPC: 5004496800). The batch code can be found on the bottom of each can. No other batches are affected.
Consumers who purchased formula from these batches should stop using it immediately and dispose of it. ByHeart will replace discarded cans at no cost.
Parents concerned about symptoms related to infant botulism should contact their healthcare provider immediately. Illnesses or adverse events can be reported directly to the FDA through various channels including phone or online forms.
For additional information or questions about this recall, consumers can contact ByHeart experts at hello@byheart.com or call 1 (833) 429-4327 at any time.
