ByHeart, a baby nutrition company, has expanded its voluntary recall to cover all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack across the United States. The company made this decision in cooperation with the U.S. Food and Drug Administration (FDA), even though unopened ByHeart products have not tested positive for Clostridium botulinum spores or toxin.
Mia Funt, Co-Founder and President of ByHeart, stated: “The safety and well-being of every infant who uses our formula is, and always will be, our highest priority. This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve."
ByHeart is recalling all affected products while an FDA investigation continues into a recent increase in infant botulism cases since August. According to the company, it began taking action after being notified on November 7, 2025.
As part of its response measures, ByHeart has started independent third-party testing on every batch of formula. It is also providing full access to its facilities for regulatory authorities like the FDA and California Department of Public Health (CDPH) so they can conduct their own testing without restrictions. Results from these tests will be shared publicly as soon as available.
Infant botulism is rare but serious; it occurs when Clostridium botulinum spores are ingested by infants and colonize their intestines, producing dangerous toxins. Symptoms may include constipation, poor feeding, drooping eyelids (ptosis), sluggish pupils, low muscle tone, difficulty sucking or swallowing, weak or altered cry, generalized weakness or respiratory problems that could lead to arrest. Parents whose children show any such symptoms are urged to seek medical attention immediately.
Consumers who purchased ByHeart Whole Nutrition Infant Formula cans or Anywhere Packs should stop using them right away and dispose of the product.
To report illness or adverse events associated with these products:
- Call an FDA Consumer Complaint Coordinator
- Complete an electronic Voluntary MedWatch form online
- Fill out a paper Voluntary MedWatch form that can be mailed
Parents seeking more information can contact ByHeart at hello@byheart.com or call 1 (833) 429-4327 at any time.
Additional details about this recall can be found through the company's website or by referencing updates from federal health agencies involved in investigating the outbreak.
