ByHeart Infant Formula Botulism Outbreak Expands, Affecting Over 50 Infants
Federal health officials have expanded the scope of an infant botulism outbreak linked to ByHeart baby formula to include all illnesses reported since the company began production in March 2022. The U.S. Food and Drug Administration (FDA) stated that investigations could not exclude the possibility that contamination may have affected all ByHeart formula products manufactured.
Scope of the Outbreak
- The outbreak now includes at least 51 infants across 19 states.
- The updated case definition encompasses any infant diagnosed with botulism who consumed ByHeart formula at any time since its product release.
- The most recent illness was reported on December 1. No fatalities have been associated with this outbreak.
- Previously, the outbreak involved 39 suspected or confirmed cases reported since August, following an increase in treatments reported by California's Infant Botulism Treatment and Prevention Program.
- An additional 12 cases were identified under the expanded definition, including two within the original timeline and ten from December 2023 through July 2025.
Company Response and Investigation
ByHeart, a New York-based organic infant formula manufacturer, initiated a recall of all its U.S. products on November 11. The company, which holds approximately 1% of the U.S. infant formula market and sold about 200,000 cans monthly, has stated its cooperation with federal officials to understand the full scope of related cases.
FDA inspectors conducted visits to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. No inspection results have been publicly released by the agency.
ByHeart previously reported that independent laboratory tests indicated 36 samples from three distinct lots contained the type of bacteria associated with infant botulism. Dr. Jennifer Cope, a CDC scientist leading the investigation, indicated that the contamination appeared to be persistent across various production runs, lots, and raw material batches.
Previous Regulatory Issues
Inspection documents reveal ByHeart's history of contamination-related issues:
- In 2022, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for Cronobacter sakazakii.
- In 2023, the FDA issued a warning letter to ByHeart, detailing outstanding corrective actions required.
- A ByHeart plant in Reading, Pennsylvania, was temporarily closed in 2023 prior to FDA inspectors discovering issues such as mold, water leaks, and insects.
Infant Botulism Information
Infant botulism is a rare condition, affecting fewer than 200 babies annually in the U.S. It occurs when infants ingest botulism bacteria, which produce spores that germinate in the intestines and release a neurotoxin. Infants under one year of age are particularly vulnerable due to their immature gut microbiomes. While baby formula has been linked to sporadic cases, no confirmed outbreaks of infant botulism tied to powdered formula have been previously documented.
Symptoms can manifest up to 30 days post-exposure and may include:
- Constipation
- Poor feeding
- Loss of head control
- Drooping eyelids
- Flat facial expression
- Generalized weakness (floppy appearance)
- Difficulty swallowing or breathing
The primary treatment for infant botulism is BabyBIG, an intravenous medication derived from the pooled blood plasma of adults immunized against botulism. This product is exclusively manufactured by California's infant botulism program. The antibodies provided by BabyBIG are most effective for approximately one month.
Legal Actions
Families of several infants treated for botulism after consuming ByHeart formula have initiated lawsuits against the company. These federal court filings allege that the formula was defective and that ByHeart was negligent in its sale, seeking financial compensation for medical expenses, emotional distress, and other damages.