Expanded Outbreak of Infant Botulism Linked to ByHeart Formula

Thu Dec 11 2025 00:30:18 GMT+0200 (Eastern European Standard Time)

Federal health authorities have broadening the scope of an infant botulism outbreak tied to ByHeart baby formula to include illnesses dating back to March 2022, amid concerns of possible contamination affecting all products. Affected infants have been reported across 19 states, raising alarm as ByHeart recalls its entire U.S. stock.

Federal health officials have expanded the investigation of infant botulism cases linked to ByHeart baby formula to include illnesses since production began in March 2022. The CDC now reports at least 51 affected infants across 19 states, with health authorities unable to rule out contamination of all ByHeart products. Parents express distress over the findings and the implications of product safety, while lawsuits against the company are anticipated.

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

The U.S. Food and Drug Administration reported investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.

The outbreak now includes at least 51 infants in 19 states. The new case definition encompasses “any infant with botulism exposed to ByHeart formula at any time since its release,” as per the U.S. Centers for Disease Control and Prevention. The latest reported case occurred on December 1.

No fatalities have been documented in the outbreak, which was first disclosed on November 8.

Previously, health officials reported an outbreak of 39 suspected or confirmed cases of infant botulism across 18 states since August. That’s when California’s Infant Botulism Treatment and Prevention Program alerted authorities about an increase in cases among infants consuming ByHeart formula. Following the expanded definition, the CDC found 10 additional cases occurring from December 2023 through July 2025.

ByHeart, a New York-based manufacturer of organic infant formula established in 2016, recalled all its products sold in the U.S. on November 11. The company, which represents approximately 1% of the U.S. infant formula market, was selling around 200,000 cans each month.

News of the contamination potentially impacting ByHeart products since their inception caused distress to parents like Andi Galindo, whose 5-week-old daughter was hospitalized due to infant botulism after consuming the formula. Galindo stated she relied on ByHeart formula to supplement her low breast milk supply upon a lactation consultant's recommendation.

“That’s a hard one,” Galindo expressed with concern. “If proof confirms issues with their manufacturing since the beginning, they must be held accountable.”

FDA inspectors visited ByHeart's facilities in Iowa and Oregon last month to investigate. Results of these inspections haven’t been made public yet.

The company had earlier indicated independent lab tests had detected botulism-causing bacteria in samples from three lots. Prior to this incident, ByHeart recalled several batches due to contamination in 2022 and received a warning from the FDA in 2023 regarding corrective action required at their manufacturing plants.

Infant botulism is a rare disease affecting less than 200 infants annually in the U.S., characterized by symptoms resulting from the ingestion of spores leading to toxin production in the intestinal system.

The only treatment available is BabyBIG, an intravenous medication sourced from the pooled plasma of adults immunized against botulism. Ongoing risks accompany the use of ByHeart formula, and affected families have initiated lawsuits against the company, claiming negligence and seeking compensation for damages and distress.