The U.S. Food and Drug Administration (FDA) is currently investigating 84 reported cases of infant botulism detected since August 2023. Of these cases, 15 involved infants who consumed ByHeart organic infant formula, according to an agency statement.
**ByHeart Formula Recall Amid Outbreak**
ByHeart, a manufacturer of organic infant formula, announced a recall of all its products sold across the United States on Tuesday. This action comes amid a growing outbreak of infant botulism linked to their powdered formula. State and federal health officials have reported that at least 15 babies across 12 states have fallen ill in connection with the outbreak—a rise from 13 cases in 10 states reported just a few days earlier. Fortunately, no deaths have been reported so far.
ByHeart officials urge parents and caregivers: if you have any of their formula at home, you should immediately stop using it and dispose of the product safely.
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### Understanding the Outbreak
The outbreak has affected infants aged between two weeks and five months. These babies were hospitalized after consuming ByHeart powdered formula, the U.S. Centers for Disease Control and Prevention (CDC) confirmed.
California health officials reported that tests on an open can of ByHeart formula, fed to an ill infant, detected the presence of the bacteria responsible for producing the toxin linked to the outbreak. These analyses involve injecting cultured bacteria into mice and observing whether the mice become ill within four days. Dr. Erica Pan, California’s state health officer, noted that “these mice got sick really quickly,” indicating the presence of the toxin.
Despite no positive tests for unopened cans, ByHeart voluntarily recalled their products in close collaboration with the FDA. Company representatives have stated that the bacterium causing the toxin is widespread in the environment and might originate from sources other than the formula.
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### FDA’s Investigation and Case Details
The FDA reported 84 infant botulism cases since August, with 15 linked to ByHeart formula. Given that ByHeart accounts for roughly 1% of all infant formula sales in the U.S., the agency highlighted that their formula is “disproportionately represented among sick infants in this outbreak.”
The illnesses started between August 9 and November 10 and have been reported in the following states:
– Arizona
– California
– Illinois
– Kentucky
– Minnesota
– North Carolina
– New Jersey
– Oregon
– Pennsylvania
– Rhode Island
– Texas
– Washington
To date, no other infant formula brands or sources have been linked to this outbreak.
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### What Is Infant Botulism?
Infant botulism is a rare illness in the U.S., typically affecting fewer than 200 babies annually. It is caused by a type of bacteria producing a potent toxin inside the large intestine. The bacteria release hardy spores found widely in soil, dust, and water.
Infants are especially vulnerable due to their immature gut microbiomes, which can’t yet prevent spores from germinating and producing the toxin. Exposure can occur through contaminated dust, dirt, water, or even honey.
Symptoms may take weeks to manifest and can include:
– Poor feeding
– Loss of head control
– Drooping eyelids
– Flat facial expression
– “Floppiness” or reduced muscle tone
– Difficulty swallowing or breathing
Notably, experts say no previous outbreaks of infant botulism have been definitively traced to powdered infant formula before this incident.
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### Treatment for Infant Botulism
The primary treatment is an intravenous medication called BabyBIG, derived from adult blood plasma immunized against botulism. Developed by California’s Infant Botulism Treatment and Prevention Program, BabyBIG is the only available treatment worldwide and helps reduce the severity of illness and length of hospitalization.
Because botulism can impair breathing, affected infants often require ventilator support. The CDC confirms that all babies linked to the ByHeart outbreak have received this treatment.
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### Impact on Infant Formula Supply
Experts say there is little risk of a broader infant formula shortage due to this recall, as ByHeart holds a small market share compared to larger manufacturers.
This contrasts with the serious formula shortage experienced in late 2021 and 2022, triggered after four infants became ill from a different germ linked to Abbott Nutrition formula products. That incident resulted in two infant deaths and a prolonged nationwide shortage after the FDA closed Abbott’s Michigan plant.
ByHeart previously recalled five batches of formula in 2022 after detecting contamination at their packaging facility, and the FDA issued a warning letter in 2023 citing ongoing corrective actions needed at the company.
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### Reviewing Infant Formula Ingredients Nationwide
In response to ongoing safety concerns, federal health officials have announced a comprehensive review of infant formula ingredients.
Health Secretary Robert F. Kennedy Jr. has initiated “Operation Stork Speed,” the first major examination of infant formula nutrient content and ingredients since 1998. The FDA is currently reviewing feedback from industry experts, health professionals, and the public to guide future regulatory actions.
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### What Parents Should Know
– If you have ByHeart infant formula at home, discontinue its use immediately and dispose of the product.
– Watch for symptoms of infant botulism in your baby, which can include poor feeding, weakness, or breathing difficulties.
– Consult your pediatrician promptly if you suspect any symptoms.
The FDA and CDC continue to monitor the situation closely and will provide updates as the investigation progresses.
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For more information and updates, please visit the FDA and CDC official websites.
https://www.boston.com/news/health/2025/11/12/baby-formula-recall-infant-botulism-outbreak/
