Federal Health Officials Expand Botulism Outbreak to All ByHeart Products

Federal health officials have expanded an outbreak of infant botulism linked to ByHeart baby formula, affecting more than 50 infants across 19 states. The U.S. Food and Drug Administration (FDA) announced that it cannot rule out contamination in all ByHeart products produced since the company began operations in March 2022. The outbreak now includes at least 51 cases, with the latest reported illness occurring on December 1, 2023.

The U.S. Centers for Disease Control and Prevention (CDC) updated its case definition to include “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release.” This adjustment reflects a rise in reported illnesses, prompting the FDA to investigate the company’s production facilities more thoroughly.

Health Concerns and Company Response

ByHeart, a New York-based manufacturer of organic infant formula, recalled all its products sold in the United States on November 11, 2023. The company, which holds approximately 1% of the U.S. infant formula market, was previously selling around $200,000 cans of formula each month. The CDC’s expanded case definition has identified an additional 10 cases occurring from December 2023 through July 2025.

Andi Galindo, a mother from Redondo Beach, California, expressed her distress after her 5-week-old daughter, Rowan, was hospitalized with infant botulism after consuming ByHeart formula. She had chosen ByHeart based on recommendations from a lactation consultant, who described it as “very natural, very gentle, very good for the babies.” Galindo emphasized the need for accountability if contamination issues have persisted since the company’s inception.

ByHeart has not yet responded to inquiries regarding the expanded outbreak. The FDA recently dispatched inspectors to ByHeart’s production facilities in Allerton, Iowa, and Portland, Oregon, but has not released the results from these inspections.

Previous Contamination Issues

Laboratory tests have indicated contamination in ByHeart’s formula. An independent laboratory found that 36 samples from three different lots contained the bacteria responsible for infant botulism. Inspection documents reveal a troubling history of contamination at ByHeart facilities. In 2022, the company recalled five batches of infant formula due to a positive test for a different pathogen, cronobacter sakazakii. In 2023, the FDA issued a warning letter to ByHeart detailing areas that required corrective actions.

In the same year, a ByHeart plant in Reading, Pennsylvania, was shut down after FDA inspectors discovered problems including mold, water leaks, and insect infestations. This history raises significant concerns about the company’s manufacturing practices and its ability to ensure product safety.

Infant botulism, while rare, affects fewer than 200 babies in the U.S. each year. It occurs when infants ingest botulism spores that germinate in their intestines, leading to toxin production that impacts the nervous system. Babies under one year old are particularly vulnerable due to their immature gut microbiomes.

Symptoms of infant botulism can take up to 30 days to manifest and may include constipation, poor feeding, loss of head control, drooping eyelids, and a flat facial expression. Affected infants may appear “floppy” and may have difficulty swallowing or breathing. The sole treatment available is BabyBIG, an intravenous medication developed from the pooled blood plasma of adults immunized against botulism.

Several families of infants treated for botulism after consuming ByHeart formula have initiated lawsuits against the company. These lawsuits, filed in federal courts, allege that the formula was defective and that ByHeart acted negligently in its sale. Claimants seek compensation for medical expenses, emotional distress, and other damages related to their children’s illnesses.

The situation continues to develop as health officials monitor the outbreak closely and families affected by this incident seek answers and support.