ByHeart Formula Contamination Prompts Expanded Infant Botulism Investigation

Thu Dec 11 2025 02:33:30 GMT+0200 (Eastern European Standard Time)

Federal health officials have expanded an investigation into infant botulism cases linked to ByHeart baby formula following reports of potential contamination in all products since production began in 2022. The situation raises alarm among parents and healthcare providers alike.

The U.S. FDA has broadened the definition of an infant botulism outbreak linked to ByHeart baby formula, with at least 51 cases reported across 19 states. The investigation reveals potential contamination in all ByHeart products since 2022. Families affected by the illness are concerned, especially as the company faces lawsuits over negligence. Symptoms of botulism can manifest up to 30 days after exposure, and the sole treatment is an IV medication called BabyBIG. As scrutiny increases, health officials continue to prioritize consumer safety.

Federal health officials on Wednesday expanded an outbreak of infant botulism linked to recalled ByHeart baby formula to include all illnesses reported since the company began producing the product in March 2022.

The U.S. Food and Drug Administration (FDA) stated that investigators cannot rule out the possibility that contamination might have affected all ByHeart formula products ever made, leading to significant public concern and distress among families of affected infants.

The outbreak now includes at least 51 infants across 19 states. The Centers for Disease Control and Prevention (CDC) has refined the case definition to encompass any infant diagnosed with botulism who has been exposed to ByHeart formula since its release, with the most recent case reported on December 1, 2023. Thankfully, no fatalities have been associated with this outbreak.

Previously, health officials had identified 39 suspected or confirmed cases of botulism in 18 states since August 2023, leading to immediate investigations and product recalls. ByHeart, a manufacturer based in New York that produces organic infant formula and constitutes about 1% of the U.S. market, issued a recall of all its products sold in the U.S. on November 11, 2025.

“It's distressing to think that ByHeart products could have been contaminated for so long,” said Andi Galindo, whose five-week-old daughter was hospitalized with botulism after consuming the formula. Families like hers are vocal about the need for accountability from the manufacturer.

The FDA has conducted inspections of ByHeart's production facilities but has not yet released results to the public. Past inspections showed that the company has had issues, including prior recalls due to contamination from pathogens like cronobacter sakazakii.

Infant botulism, while rare, can affect fewer than 200 babies in the U.S. each year. Symptoms may not manifest for up to 30 days following ingestion and can include constipation, poor feeding, and muscle weakness. The only cure, known as BabyBIG, is made from the pooled blood plasma of adults who have been immunized against botulism.

As the investigation continues, families affected by this crisis are taking action, filing lawsuits against ByHeart alleging negligence in the safety of their products.