Key Links

Keylinks Right Menu 

Licensure Key Links

Keylinks Licensure

Multi-State Outbreak of Infant Botulism Linked to ByHeart Infant Formula 

The Louisiana Department of Health (LDH) is issuing this health advisory to alert clinicians about a 

 and assist in identification and management of suspected cases. 

To date, no cases have been identified in Louisiana.

 has been identified in the United States. As of November 14, 2025, this outbreak includes 23 infants with suspected or confirmed infant botulism from 13 states (

). All 23 infants were hospitalized and treated with BabyBIG® (Botulism Immune Globulin Intravenous medication). No deaths have been reported.

The CDC National Botulism Surveillance System records approximately 150-180 infant botulism cases each year. In 2024, over half of infants with infant botulism were exclusively breastfed and 43% were receiving powdered infant formula before becoming ill.  According to information shared by the 

Infant Botulism Treatment and Prevention Program (IBTPP)

, since August 1, 2025, through November 10, 2025, 84 infants nationwide have received BabyBIG® treatment.

Data from IBTPP have demonstrated a concerning association between consumption of ByHeart infant formula and botulism. Among the 84 infants recently receiving BabyBIG® treatment, 36 (43%) had any powdered infant formula exposure. Notably, more than 40% (15) consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given Food and Drug Administration’s (FDA) data that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations are ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants at this time.

 that parents and caregivers immediately stop use of all ByHeart Whole Nutrition infant formula, including cans and single serve packets.

 On November 11, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products. FDA does not anticipate any formula shortages as a result of this outbreak.

Infant botulism occurs when an infant ingests spores from a type of bacteria called 

, which then grows in the large intestine and produces toxin that blocks the neuromuscular junction by inhibiting the release of acetylcholine. Initial signs and symptoms often include constipation, difficulty feeding (difficulty sucking or swallowing), loss of head control, weak facial expression, and reduced muscle tone. Without prompt recognition and treatment, descending paralysis may progress and involve the respiratory muscles, potentially leading to life-threatening respiratory failure. The time from ingestion to symptom presentation can be up to 30 days.

Recommendations for Healthcare Professionals

Consider infant botulism a clinical diagnosis

 in any infant presenting with unexplained weakness, poor feeding, decreased head control, or difficulty swallowing — especially if the infant has consumed ByHeart formula.

Immediate actions when suspecting a case:

Caregiver guidance when ByHeart formula was used: