All ByHeart Whole Nutrition Infant Formula products have been recalled pending an investigation by the U.S. Food and Drug Administration into possible health risks to infants connected to a Clostridium botulinum contamination. ByHeart Formula has been connected to a potential foodborne illness known as infant botulism.
If your infant consumed ByHeart Whole Nutrition Infant Formula and has since been diagnosed with botulism, your family may have the right to take legal action. The nationally recognized product liability attorneys at Goldenberg Lauricella, PLLC are ready to fight for justice on your behalf. We can assess your case, explain your legal rights and help you find a way forward.
Our Minneapolis product liability lawyers have achieved life-changing case results for our product liability clients in and out of court. We are a family-oriented law firm that is prepared to be with you until the end. Contact us to begin with a free case review with a knowledgeable attorney. We do not charge any fees unless we win.
What to Do If Your Baby Was Fed ByHeart Formula
If you have any formula products by ByHeart in your home, discontinue their use immediately. Keep the packages and document them by taking photos, especially of the bottoms of the packages. Keep the container out of reach of children and label it with “DO NOT USE.” If your child does not develop symptoms, dispose of the containers.
If your child was fed a ByHeart product, watch carefully for potential symptoms of infant botulism. Symptoms may arise even several weeks after feeding, and can include constipation, drooping eyelids, decreased facial expression, trouble feeding or swallowing, weak or unusual cry, loss of head control, generalized weakness, trouble breathing, and respiratory arrest. If your child exhibits any of these symptoms, seek medical attention immediately.
Legal Rights of Families Affected by the ByHeart Recall
On November 11, 2025, all ByHeart Whole Nutrition Infant Formula products were recalled following a multistate infant botulism outbreak. As of December 2025, 51 infants in 19 states were hospitalized with suspected or diagnosed botulism and confirmed exposure to various ByHeart formula products.
Now, many of these families are pursuing financial compensation through product liability claims against ByHeart.
Grounds for a ByHeart Botulism Lawsuit
The ByHeart botulism lawsuits that are currently being filed around the nation allege that the manufacturer of the formula failed to prevent the contamination of its products, failed to warn consumers of known risks and continued to sell products that could pose a deadly risk to infants.
You may have grounds for a lawsuit if your infant:
- Consumed a recalled ByHeart Whole Nutrition Infant Formula product.
- Developed symptoms of infant botulism.
- Was confirmed or suspected to have infant botulism by a physician.
- Required emergency treatment, hospitalization or medical care.
- Suffered harm or health complications you believe are connected to ByHeart Formula products.
If you think your family has grounds for a ByHeart botulism lawsuit, contact Goldenberg Lauricella, PLLC for a cost-free case evaluation. We will carefully review your circumstances to determine if your case has merit.
What Compensation May Be Available to Your Family
A product liability claim for botulism connected to the ByHeart Formula recall could result in financial compensation for your family’s related costs and losses. This includes your child’s illness, treatments, medical care (past and future), long-term health effects, your lost wages from missed work, travel and out-of-pocket costs, and pain and suffering.
What Is Infant Botulism?
Infant botulism is a rare but potentially fatal illness that is spread through Clostridium botulinum spores. If left untreated, it can cause a slow form of paralysis that ultimately leads to trouble breathing and the potential for infant death. However, most babies make a full recovery when properly treated.
How Clostridium Botulinum Affects Infants
Infant botulism is a medical emergency that occurs when the bacterium Clostridium botulinum is ingested by a child under the age of one. Once introduced to a baby’s system, the spores can colonize in the infant’s intestinal tract and produce botulinum neurotoxins in the gut. This can ultimately disrupt the infant’s nervous system and cause symptoms.
Why Infants Are Uniquely Vulnerable
Children under one year old, and especially those six months or younger, are especially vulnerable to illness from Clostridium botulinum exposure due to their undeveloped guts. Older children have healthy bacteria in their guts that can typically keep Clostridium botulinum from colonizing and making the toxin. However, the gut microbiomes of newborns and infants are not equipped to provide adequate protection.
Frequently Asked Questions About the ByHeart Recall
Q: Which ByHeart Formula products were recalled?
A: ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs are included in the recall. All batch codes and use-by dates for the following products are recalled:
- ByHeart Whole Nutrition Infant Formula, 24 oz can, UPC: 5004496800
- ByHeart Whole Nutrition Infant Formula, 0.60 oz Anywhere Pack™, 14 packets per package, UPC: 5004496802
These products were distributed nationwide online and through retail stores, including Target, Walmart, Whole Foods Market, Kroger, Publix, Sam’s Club and ByHeart.com.
Q: How soon after exposure do infant botulism symptoms appear?
The symptoms of infant botulism typically appear within 3 to 30 days after ingesting Clostridium botulinum spores. However, it can take up to several weeks for symptoms to become noticeable. Symptoms may arise earlier if a large amount is ingested.
Q: What is the deadline to file a ByHeart botulism lawsuit?
The deadline to file a ByHeart botulism lawsuit depends on the state, but typically ranges from one to three years from the date that the illness was diagnosed. The filing deadlines for most cases connected to the ByHeart recall are expected to occur at the end of 2026 or 2027.
Q: How do I know if my baby’s formula lot number was part of the recall?
Check the bottom of the container for a multidigit code and compare it to the lot numbers listed above. If you have already discarded the container, review your purchase history using your receipt, a retailer’s website or bank statements to match the date of purchase with the dates of the recall.
Q: Does infant botulism require hospitalization?
Yes. Infant botulism is a medical emergency that requires immediate medical intervention to treat the child and prevent potentially life-threatening symptoms.
How to Pursue an Infant Botulism Recall Claim
If your child has been diagnosed with infant botulism after being exposed to ByHeart Whole Nutrition Infant Formula, seek counsel from a personal injury lawyer at Goldenberg Lauricella, PLLC without delay.
We have been representing clients and their families in national product recall cases for more than 40 years. Our team can help your family understand your legal rights and take the first steps toward seeking justice. Contact us for a free case consultation.