ByHeart, the producer of the popular ByHeart Whole Nutrition Infant Formula, was notified on November 7 by the Food and Drug Administration (FDA) about an infant botulism outbreak investigation. The company chose to withdraw two batches of the product from the market.
The FDA counted 83 cases of botulism in US infants since August 2025, with 13 of those cases involving infants who received the baby formula.
In a statement, ByHeart said a direct link between its products and the botulism outbreak has not been definitively found, but that the company is taking a precautionary measure regardless.
Botulism is caused by Clostridium botulinum, a bacterium that produces a toxin that affects the body’s nervous system and can be fatal. Botulism not only affects food storage; it is also often associated with the misuse of Botox injections for both cosmetic and medical purposes, and it can even develop in babies, as this national outbreak proves.
In this gallery, you’ll learn all about botulism, including its symptoms, treatment, and whether it can be prevented. Click on for more.