ByHeart, a company specializing in baby nutrition, has expanded its voluntary recall to include all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack products nationwide. The decision comes as the company works with the U.S. Food and Drug Administration (FDA) amid concerns over potential contamination with Clostridium botulinum, a bacterium that can cause infant botulism.
According to ByHeart, no unopened product has tested positive for Clostridium botulinum spores or toxin so far. However, the recall is being implemented as a precautionary measure while investigations continue.
“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 stated it is recalling all affected products from the market during the FDA’s ongoing investigation into a broader outbreak of infant botulism cases. The company has begun testing every batch of formula through an independent third-party laboratory. Additionally, ByHeart is providing full access to its facilities for regulatory agencies such as the FDA and California Department of Public Health (CDPH) for further testing.
The FDA and Centers for Disease Control and Prevention (CDC) have been investigating an increase in infant botulism cases since August, totaling 84 reported incidents. ByHeart was notified on November 7, 2025, about possible links between their product and these cases. The outcome of these investigations will guide any further actions by the company.
Infant botulism is described as a rare but serious illness caused when infants ingest Clostridium botulinum spores that then produce toxins in their intestines. Symptoms may include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty sucking or swallowing, weak or altered cry, generalized weakness, respiratory difficulties or arrest.
Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans or Anywhere Packs are advised to stop using them immediately and dispose of any remaining product. Parents whose children show symptoms associated with infant botulism should seek medical attention without delay.
For more information or assistance regarding the recall or reporting adverse events related to this product, consumers can contact ByHeart at 1 (833) 429-4327 at any time.
