A rare infant botulism outbreak tied to ByHeart baby formula has hospitalized more than 50 American babies.

Story Highlights

• At least 51 infants in 19 states have suspected or confirmed botulism after consuming ByHeart powdered formula.
• FDA and CDC urged parents to stop using all ByHeart products after bacteria was found in opened and unopened cans.
• The nationwide recall raises hard questions about years of weak oversight of critical baby formula plants.

How a Trusted Formula Brand Ended Up in a Nationwide Botulism Outbreak

U.S. health officials say a rare outbreak of infant botulism has been traced to ByHeart Whole Nutrition powdered infant formula, a brand that marketed itself as carefully controlled and higher quality. Clinicians and California’s Infant Botulism Treatment and Prevention Program first saw an unusual spike in type A infant botulism cases in August 2025 among babies who had consumed ByHeart formula. Lab testing later detected the botulism-causing bacterium, Clostridium botulinum, in both opened and unopened ByHeart containers.

Federal and state investigators report that at least 51 infants across 19 states have suspected or confirmed botulism linked to ByHeart formula exposure, and every single one of those children required hospitalization. The earliest known illness began on August 9, 2025, and new cases continued into late November as families slowly learned of the risk. Authorities emphasize that, so far, no deaths have been reported, but the infants have faced intensive care and, in many cases, significant respiratory support.

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From Limited Recall to All ByHeart Products: What Parents Need to Know

After early testing pointed to contamination in specific ByHeart lots, the company initially recalled just two identified batches of Whole Nutrition Infant Formula on November 8, 2025. Within days, as more cases appeared and additional lot codes surfaced, the Food and Drug Administration concluded it could not rule out wider contamination. On November 11, at FDA’s request and with a broader Centers for Disease Control and Prevention case definition, ByHeart expanded its recall to every formula product it had on the market.

Regulators now advise parents and caregivers to avoid all ByHeart infant formula products, including cans and single-serve stick packs, because even sophisticated testing can miss low levels of Clostridium botulinum in powdered foods. ByHeart says its retained product testing also found the bacterium in an unopened sample, underscoring concern that the problem reaches back into manufacturing or upstream supply, not just household handling. Investigators are continuing root-cause work, but until that is complete, families are urged to discard any ByHeart formula and switch to safer alternatives.

Botulism outbreak sickens more than 50 babies and expands to all ByHeart products | Click on the image to read the full story https://t.co/qYwASxsENn

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What This Means for Families and Medical Providers

For parents, the guidance is brutally simple: do not feed your baby any ByHeart product and contact a doctor immediately if you see signs like poor feeding, weak cry, constipation, or muscle weakness. Hospitals and pediatricians are working closely with California’s Infant Botulism Treatment and Prevention Program, which supplies the BabyBIG antitoxin that is uniquely used for these rare cases. Heavy use of that scarce treatment during this outbreak shows how avoidable manufacturing failures can strain even highly specialized medical systems.

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Sources:

Outbreak Investigation of Infant Botulism: Infant Formula (FDA)
2025 Infant Botulism Outbreak Linked to Infant Formula (Washington DOH)
An Update from Our Founders on Our Voluntary Recall (ByHeart)
California Confirms Infant Botulism Cases Linked to Infant Formula (CDPH)
Infant Botulism Outbreak Linked to Infant Formula (CDC)
Infant Botulism Cases Linked to Baby Formula (Minnesota Department of Health)