ByHeart Baby Formula Linked to Infant Botulism Outbreak

Mon Nov 10 2025 01:15:01 GMT+0200 (Eastern European Standard Time)

At least 13 infants across 10 states have fallen ill due to a recent botulism outbreak linked to ByHeart's Whole Nutrition Infant Formula, leading to an urgent recall of certain lots of the product.

Health officials in California confirmed that a bacteria producing botulism toxin was found in ByHeart baby formula samples. The outbreak has affected 13 infants in 10 states, prompting a recall of two lots with a best-by date of December 2026. Parents are urged to stop using the affected product immediately. Botulism, although rare, can cause severe illness and symptoms, particularly in infants under one year of age. Treatment options exist, but the spread of bacteria can occur through environmental spores, putting infants at risk. Authorities are investigating 83 reported botulism cases related to the formula.

California health officials have discovered troubling bacteria in ByHeart baby formula, linking it to an ongoing outbreak of infant botulism that has already made 13 babies sick across 10 states.

The situation prompted the company to recall two lots of its Whole Nutrition Infant Formula, which carries a best-by date of December 2026. Health officials are advising consumers to stop using the product immediately.

Testing indicated the presence of bacteria that can produce the botulism toxin, although more results are still pending to determine the exact nature of the bacteria, said officials. The investigation is focused on babies aged 2 weeks to 5 months who were hospitalized after consuming the formula.

ByHeart, founded in 2016, represents about only 1% of the U.S. formula market, significantly less than major players like Abbott. However, this outbreak follows a disturbing trend of quality control issues within the formula industry following last year's supply crisis.

Botulism symptoms include difficulty feeding and breathing, and while treatment exists, preventative measures are essential to protect vulnerable infants.