Archive · 12 Nov 2025
ByHeart Expands Infant Formula Recall Amid Botulism Outbreak
A company called ByHeart makes baby food called infant formula.
Some babies have gotten very sick with a problem called infant botulism, which can make them weak and unable to eat well.
ByHeart first took back some of their baby food, but now they are taking back ALL of their baby food because more babies are getting sick.
This is happening in many places across the country, and 15 babies have had to go to the hospital.
The government health experts, called the CDC and FDA, are telling everyone to stop using this baby food right away.
They are trying to figure out exactly why the babies are getting sick from the formula.
If you have this baby food, you should throw it away, and the company will help you get new food or your money back.
ByHeart has expanded its voluntary recall to include all its Whole Nutrition infant formula products nationwide.
The expansion is due to an increasing outbreak of infant botulism, with 15 infants hospitalized across 12 states.
Symptoms of infant botulism appeared between August 9 and November 10 for most affected infants.
All hospitalized infants received treatment with BabyBIG, and no deaths have been reported.
The CDC and FDA are urging consumers to immediately stop using and dispose of all ByHeart infant formula.
- Who
- ByHeart, the US Centers for Disease Control and Prevention (CDC), and the US Food and Drug Administration (FDA)
- What
- Expanded recall of all ByHeart Whole Nutrition infant formula products due to an ongoing infant botulism outbreak.
- When
- Recall expanded on Tuesday; cases reported nationwide since August 9.
- Where
- Nationwide in the United States; 15 infants affected across 12 states.
- Why
- To address concerns over infant botulism linked to the formula, with an increasing number of hospitalized infants.
ByHeart's Position
CDC/FDA's Position
Recall Scope
ByHeart's Position
ByHeart initially recalled two lots of its formula but expanded to all unexpired lots of cans and single-serve sticks due to potential contamination concerns.
CDC/FDA's Position
The CDC and FDA warned that additional lots beyond the initial recall may be contaminated and linked to illnesses, leading to the expanded recall.
Causality
ByHeart's Position
ByHeart initiated the recall voluntarily due to an increasing number of infant botulism cases linked to their product.
CDC/FDA's Position
The CDC and FDA are investigating ongoing illnesses and potential contamination of ByHeart formula, noting an increase in infant botulism cases and urging consumers to stop using the product.
- Company
- ByHeart
- Product
- Whole Nutrition infant formula (cans and single-serve sticks)
- Reason for Recall
- Infant botulism outbreak
- Affected Batches
- All unexpired lots nationwide
- Hospitalized Infants
- 15 infants in 12 states
- Symptom Onset
- Between August 9 and November 10 (for 14 cases)
- Treatment
- All 15 infants hospitalized and treated with BabyBIG
- Deaths Reported
- No
