Infant Botulism Outbreak: Investigation Expands to All ByHeart Formula Products
Federal health officials have expanded an investigation into an outbreak of infant botulism linked to ByHeart baby formula, now including all illnesses reported since the company began production in March 2022. The U.S. Food and Drug Administration (FDA) has stated that investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made. This development has significant implications for parents and caregivers who have used ByHeart formula, as it suggests that the risk of contamination may have been present throughout the product’s entire production run.
The outbreak, which was first announced on November 8, has now grown to include at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention (CDC). The most recent illness was reported on December 1, and fortunately, no deaths have been reported in the outbreak. The CDC’s expanded definition has identified an additional 12 cases, including two that occurred within the original timeline and 10 that occurred from December 2023 through July 2025.
Background on ByHeart and the Outbreak
ByHeart, a New York-based manufacturer of organic infant formula, recalled all its products sold in the U.S. on November 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling approximately 200,000 cans of the product each month. The recall and expanded investigation have caused concern among parents who used ByHeart formula, including Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo expressed her distress, stating, “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”
Amy Mazziotti, another parent whose child was affected, shared her experience, saying, “I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears — a mix of relief, gratitude and hope that the truth is finally being recognized.” ByHeart officials have stated that the company is cooperating with federal officials “to understand the full scope of related cases” and that “the new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination.”
Lab Tests and Inspection Findings
Lab tests have detected contamination in ByHeart formula, with 36 samples from three different lots containing the type of bacteria that can cause infant botulism. The FDA sent inspectors to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged, but has not released the results of those inspections. Dr. Jennifer Cope, a CDC scientist leading the investigation, noted that “it looks like the contamination appeared to persist across all production runs, different lots, different raw material lots” and that “they couldn’t isolate it to specific lots from a certain time period.”
Inspection documents have also revealed a history of problems with contamination at ByHeart, including a recall of five batches of infant formula in 2022 due to the presence of Cronobacter sakazakii and a warning letter from the FDA in 2023 detailing “areas that still require corrective actions.” A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 due to issues with mold, water leaks, and insects.
Understanding Infant Botulism
Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It is caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin. Symptoms can take up to 30 days to develop and may include constipation, poor feeding, loss of head control, drooping eyelids, and a flat facial expression.
The sole treatment for infant botulism is BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. Dr. Sharon Nachman, an expert in pediatric infectious disease, emphasized that “the risk to the infant is ongoing and the family should not be using this formula after it was recalled.” Families of several babies treated for botulism after drinking ByHeart formula have sued the company, alleging that the formula was defective and ByHeart was negligent in selling it.
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