ByHeart Botulism Outbreak: All Products Affected
- This article details a growing outbreak of infant botulism linked to ByHeart, an organic infant formula manufacturer.
- * Outbreak Scope: As of November 2025, 30 cases of infant botulism have been reported in 18 states since August.
- The article highlights concerns about ByHeart's response to the outbreak and the potential for long-term contamination issues within their manufacturing processes.
Summary of the ByHeart Infant Formula Botulism Outbreak (as of november 15, 2025)
This article details a growing outbreak of infant botulism linked to ByHeart, an organic infant formula manufacturer. Here’s a breakdown of the key information:
* Outbreak Scope: As of November 2025, 30 cases of infant botulism have been reported in 18 states since August. The CDC identified 10 additional cases dating back to December 2023 with an expanded definition of the outbreak.
* Recall: ByHeart recalled all its products sold in the U.S. on November 11th. The company represents about 1% of the US infant formula market, selling approximately 200,000 cans monthly.
* Contamination: Lab tests revealed the presence of bacteria capable of causing infant botulism in 36 samples from three different lots of ByHeart formula.
* Past issues: ByHeart has a history of contamination problems. In 2022, they recalled five batches due to cronobacter sakazakii. In 2023, the FDA issued a warning letter citing needed corrective actions, and a plant in Pennsylvania was shut down due to issues with mold, leaks, and insects.
* Patient Impact: andi Galindo’s 5-week-old daughter, Rowan, was hospitalized with infant botulism in December 2023 after consuming ByHeart formula. Galindo feels the company should be held accountable if issues existed from the beginning.
* FDA Examination: The FDA inspected ByHeart plants in Iowa and Oregon last month, but results haven’t been released yet.
* Infant Botulism: The disease is rare, affecting fewer than 200 babies annually in the US. It occurs when infants ingest botulism bacteria spores that produce toxins in the intestines, impacting the nervous system.
The article highlights concerns about ByHeart’s response to the outbreak and the potential for long-term contamination issues within their manufacturing processes.