ByHeart Formula Recall

On Nov 11 2025, The U.S. Food and Drug Administration (FDA) announced a recall of ALL ByHeart formula products due to a potential risk of infant botulism and a preliminary positive sample tested by the CA health department. As of Nov 10, a total of 15 infants with confirmed/suspected botulism had confirmed exposure to ByHeart Whole Nutrition infant formula (various lots).

What are the next steps?

Parents and caregivers should immediately STOP using any ByHeart formula immediately.
Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher
Take pictures of the formula info on the bottom and store it in a safe spot, labeling DO NOT USE
- Reason: If your child develops symptoms, the state health department may want to collect the formula for testing
If no symptoms after 30 days, throw out formula

What do I monitor for?

Infant botulism symptoms range from mild to severe beginning with:
- Constipation (painful large or hard stools)
- Weakened and altered cry
- Loss of facial expression
- Reduced gag reflex
- Slow and poor feeding
- Overall weakness or floppiness (ie, loss of head control and drooping eyelids)
The typical time period from exposure/ingestion to symptoms (incubation period) for infant botulism can range from 3 to 30 days. Rarely, symptoms can take several weeks to develop so parents should remain vigilant
Remember, constipation is a common concern in infants and botulism is not common in the US. The vast majority of constipation is not caused by infant botulism

What do I do if my child has symptoms?

Call our office and seek medical care IMMEDIATELY
Early diagnosis and treatment with BabyBIG (Botulinum toxin- neutralizing antibody) is KEY
Untreated cases can lead to progressive paralysis that can lead to breathing difficulties

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