ByHeart Baby Formula Linked to Infant Botulism Outbreak, Recall Issued

Mon Nov 10 2025 00:31:59 GMT+0200 (Eastern European Standard Time)

Health officials have issued a recall after preliminary tests found bacteria linked to a botulism outbreak in ByHeart baby formula, affecting at least 13 infants across 10 states.

California health officials have warned consumers against using ByHeart's Whole Nutrition Infant Formula after preliminary tests revealed the presence of bacteria associated with a botulism outbreak that has sickened 13 infants in 10 states. The company has recalled two lots of the product with a best-by date of December 2026 as federal investigations continue. Symptoms of infant botulism can be severe, including paralysis and respiratory issues, necessitating immediate medical treatment. Health officials also plan a comprehensive review of infant formula ingredients.

California health officials have issued a severe warning for parents regarding ByHeart baby formula, as preliminary tests have detected bacteria associated with a botulism outbreak. This alarming news follows reports that at least 13 infants across 10 states have fallen ill after consuming the product.

The California Department of Public Health stated, “Consumers in possession of this product should stop using it immediately,” emphasizing the urgency of the situation. The recalled lots of ByHeart Whole Nutrition Infant Formula have a best-by date of December 2026.

Health officials highlight that the infants affected, aged between two weeks to five months, were hospitalized after using ByHeart's formula since mid-August. The investigation into this troubling outbreak is ongoing, with more tests anticipated.

Understanding Infant Botulism

Infant botulism, which can affect fewer than 200 babies in the U.S. each year, is a serious condition caused by toxins produced in the intestines from a specific bacteria. Infants, especially those under one year old, are at heightened risk from exposure to environmental spores, often found in soil and dust. Symptoms can take time to appear, include poor feeding, weak muscle tone, and breathing difficulties, and can lead to hospitalization.

Currently, all the infants involved in the outbreak are receiving treatment with BabyBIG, a specialized medication designed to combat the effects of botulism. The CDC confirmed that these children have received this essential care.

No Immediate Risk of Formula Shortage

Despite concerns surrounding this outbreak, there is currently no risk of a national shortage of infant formula linked to ByHeart, which accounts for only 1% of the market. This is significantly different from the 2022 crisis involving Abbott Laboratories, which had a substantial impact due to a contamination incident.

As policies around infant formula manufacturers come under scrutiny, federal officials are initiating a comprehensive review to enhance safety standards.

Parents and caregivers are urged to remain vigilant and seek immediate medical attention for any concerning symptoms in their infants.