Every parent wants to give their baby the best kind of formula, but what happens when trusted a baby-formula could cause serious illness, or even death?
On November 8th 2025, the Food and Drug Administration and Centers for Disease Control and Prevention announced an investigation into an outbreak of infant botulism stemming from ByHeart Whole Nutrition Infant Formula. As a result of this finding, the FDA issued an official recall of the product.
As more cases came out, ByHeart also issued their own voluntary nationwide recall alongside the FDA. Hospitals and retailers have pulled their products from shelves to prevent further harm. Despite this, families who used their product are now in panic, unsure of what this recall covers, what this means for their baby, and what they can do about it.
What Parents Need to Know About the ByHeart Recall
On November 11 2025, ByHeart worked to voluntarily recall their products. This recall includes all ByHeart Whole Nutrition Infant Formula cans and any Anywhere Pack single-serve sticks. The company urged parents to stop using their product immediately, advising them to request a refund directly from the company. The FDA confirmed that an opened container tested positive for bacteria capable of producing botulinum toxin, which causes infant botulism.
Understanding Infant Botulism and Its Warning Signs
Infant botulism is a rare illness, but is severe for anyone who contracts it. A spore, known as Clostridium botulinum, grows inside the intestines and releases toxins, affecting the nervous system. Since it grows gradually, early symptoms often go unnoticed until they become life-threatening. Some symptoms infants may include:
- Constipation
- Difficulty swallowing or breathing
- Lethargy
If your infant is experiencing any of these symptoms, get medical attention immediately. Depending on the stage of the illness, hospitals can treat infant botulism with an antitoxin called BabyBIG®.
What to Do If You Used ByHeart Formula
If you have been feeding your infant ByHeart infant formula and you just discovered this recall, don’t panic. What you should do is:
- Stop using all ByHeart products– Regardless of lot code or packaging, do not share it.
- Preserve all evidence- Save all cans, packaging, lot numbers, purchase receipts, and medical records.
- Contact your pediatrician- Set up a check-up and mention the brand name and the recall to your doctor so they can evaluate the symptoms.
- Wash any contaminated supplies- This includes bottles, scoops, or utensils that came in contact with the formula.
- Submit a report- Enter the FDA MedWatch portal if your infant experiences any symptom.
How the ByHeart Recall Impacted Hospitals and Supply Chains
Ever since the ByHeart recall, families are not the only ones concerned, hospitals and retail supply chains have their own concerns. While the company only represents a small percent of the infant-formula market in the United States, its overrepresentation of botulism cases raises questions about manufacturing practices.
Advocates and pediatric health experts have criticized ByHealth’s early public statement for being “bizzare”. In their criticism, advocates believe the language used makes it seem like a caution, implying the risk was low.
What Families Can Do if ByHeart Formula Caused Harm
Families whose infants have become ill after consuming ByHeart infant formula may have rights under product-liability and wrongful-death laws. It’s important to seek an attorney that can help:
- Trace contamination sources
- Review hospital and autopsy records
- Preserve and test remaining formula samples
- Demand full compensation on your behalf
The ByHeart recall is a prime example of why product safety should never be taken for granted. If your infant was affected by using ByHeart formula, take the first steps to bring justice for your baby.
