NEW YORK, New York — ByHeart, a baby nutrition company, has expanded its voluntary recall to include all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack products nationwide. The decision was made in coordination with the U.S. Food and Drug Administration, even though no unopened ByHeart products have tested positive for Clostridium botulinum spores or toxin. The company said the expanded recall reflects its commitment to prioritize infant safety.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Mia Funt, Co-Founder and President of ByHeart. “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 taking several steps while the FDA continues its investigation:
The company is recalling all formula products currently on the market while federal health officials determine the root cause of an ongoing broader outbreak. ByHeart has begun testing every batch of formula through an independent third-party laboratory. The company is also providing the FDA and the California Department of Public Health full access to its facilities and unopened product for unrestricted testing. Results from both regulatory and independent testing will be shared publicly as they are confirmed.
Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and begin producing toxins in an infant’s intestinal tract. Symptoms may include constipation, difficulty feeding, drooping eyelids, poor muscle tone, weak crying, or breathing problems. Parents who notice these symptoms should seek medical care immediately.
Federal agencies have been investigating an increase in infant botulism cases since August. ByHeart was notified of a possible link on November 7, 2025, and initiated its recall shortly afterward. The results of the broader federal investigation will determine any additional steps.
Consumers who have purchased ByHeart Whole Nutrition Infant Formula or Anywhere Pack products should stop using them and dispose of them.
Families can report illnesses or adverse events through the FDA, either by speaking with a consumer complaint coordinator, filing an online MedWatch report, or submitting a printed MedWatch form by mail.
