New York, NY – ByHeart, a next-generation baby nutrition company, has announced an expansion of its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ products nationwide. This decision comes in close collaboration with the U.S. Food and Drug Administration (FDA), despite no unopened ByHeart products testing positive for Clostridium botulinum spores or toxins. This proactive measure emphasizes ByHeart’s core mission: safeguarding the health of infants above all else.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” stated Mia Funt, Co-Founder and President of ByHeart. “This nationwide recall reflects our commitment to protecting babies and providing families with clear, actionable information.” Alongside the recall, ByHeart is undertaking a comprehensive investigation to deliver the answers that parents expect and deserve.
While the FDA continues its investigation, ByHeart is taking significant steps to protect families. The company has initiated the following actions:
Recalling all products from the market while the FDA's comprehensive investigation seeks to identify the root cause of the outbreak. Testing every batch of formula with an independent third-party laboratory—a process that has already commenced. Providing the FDA and the California Department of Public Health (CDPH) full access to its facilities and unopened cans for unrestricted testing. Publicly sharing results from both regulatory and independent testing as they become available.Infant botulism is a rare yet serious illness caused by the ingestion of Clostridium botulinum spores, which can colonize the intestinal tract and produce dangerous neurotoxins in infants. Symptoms of this condition may include:
Constipation Poor feeding Ptosis (drooping eyelid) Sluggish pupils Low muscle tone Difficulty sucking and swallowing Weak or altered cry Generalized weakness Respiratory difficulty, potentially leading to respiratory arrestIf your child exhibits any of these symptoms, it is crucial to seek medical attention immediately.
The FDA and CDC are currently investigating a spike in 84 infant botulism cases that began in August. Upon being alerted on November 7, 2025, ByHeart acted swiftly to address the situation. The findings from the FDA’s investigation into these broader cases will inform any additional measures as ByHeart's own investigation progresses.
Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs™ are urged to:
Immediately discontinue use and dispose of the product. If your infant is showing symptoms related to infant botulism, contact your healthcare provider without delay.To report an illness or adverse event, consumers can:
Call an FDA Consumer Complaint Coordinator for direct assistance. Complete an electronic Voluntary MedWatch form online. Fill out a paper Voluntary MedWatch form and mail it to the FDA.For any inquiries, parents can reach out to ByHeart’s experts at hello@byheart.com. For more information, visit byheart.com or call 1 (833) 429-4327. Customer support is available 24/7.
For media inquiries, please contact ByHeart Public Relations at press@byheart.com.
The voluntary recall now applies to all batches of ByHeart Whole Nutrition Infant Formula cans and all Anywhere Packs:
Can UPC: 85004496800 Anywhere Pack (™) UPC: 85004496802For further details and updates, please refer to the original recall announcement.
