Questions?About the ByHeart Formula Recall 2025
In November 2025, ByHeart baby formula was recalled after the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and state health agencies linked the product to a multistate outbreak of infant botulism.
ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinum, causing illness in dozens of infants across the United States.
The illnesses started between December 24, 2023, and December 1, 2025, according to the FDA. The infants range in age from 16 to 264 days, and all 51 were hospitalized.
Authorities are actively working to remove contaminated formula from store shelves nationwide, and the company can issue a refund for your purchase. Under no circumstances should you give these products to your child if you still have them.
What Is Infant Botulism?
Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria, which can produce toxins in a baby’s intestines and interfere with nerve function.
It most commonly affects infants under 1 year old and can result from consuming contaminated food like powdered infant formula.
Common symptoms of infant botulism include:
- Constipation
- Lethargy or unusual sleepiness
- Muscle weakness or floppy movements
- Poor feeding or difficulty swallowing
- Trouble controlling head or neck muscles
- Weak cry or voice
Infant botulism requires immediate medical attention. Prompt diagnosis and treatment in a hospital setting are critical to reduce complications, support recovery, and prevent long-term health issues.
What ByHeart Formula Was Recalled?
All ByHeart baby formula products were recalled, including powdered formula and single-serve Anywhere Pack™ sticks.
The ByHeart formula recall affects these products:
- ByHeart Organic Stage 1 Infant Formula
- ByHeart Organic Stage 2 Infant Formula
- ByHeart Whole Nutrition Infant Formula – Anywhere Pack Sticks
- ByHeart Whole Nutrition Infant Formula – Powdered
These recalled products should not be used, and families who purchased them are urged to stop feeding them to their infants and seek legal guidance if their child was harmed.
“ByHeart’s and FDA’s investigations into the root cause of the outbreak are ongoing, and at this time, FDA cannot rule out the possibility that contamination might have affected all ByHeart formula products.”
– U.S. Food and Drug Administration (December 10, 2025)
ByHeart Formula Health Risks
ByHeart baby formula has been linked to serious health risks like infant botulism due to Clostridium botulinum bacteria contamination. Infants who consumed contaminated formula have experienced digestive issues, infections, and symptoms of botulism.
These health risks are particularly dangerous for babies, whose immune and digestive systems are still developing. Because infant botulism can interfere with nerve function and breathing, prompt medical attention is critical for any child showing symptoms after consuming the formula.
Families who purchased or fed their infants ByHeart formula are advised to stop use immediately and consult a health care professional if any signs of illness appear. Some families are filing ByHeart lawsuits to seek compensation for medical expenses, emotional distress, and other harms caused by the tainted formula.
Get Help Filing a ByHeart Lawsuit
The Birth Injury Justice Center can help affected families understand what’s happening to their child and determine their next steps.
Our legal partners have handled a variety of tainted baby formula cases and know what it takes to win, holding powerful corporations accountable for harming children.
Get a free case review now to start filing a ByHeart formula lawsuit.
ByHeart Recall Lawsuit FAQs
Is ByHeart infant formula safe?
No. ByHeart infant formula is not safe right now. Federal health officials linked several cases of infant botulism to the company’s powdered formulas, and all ByHeart products were recalled. If a baby drank this formula and now has trouble feeding, constipation, a weak cry, or unusual sleepiness, contact a doctor right away.
Has ByHeart tested positive for botulism?
Yes. Federal health officials found botulinum bacteria in ByHeart’s powdered infant formula during their investigation. This bacteria can cause infant botulism, a serious illness. Because of this finding, all ByHeart formula products were recalled and should not be used.
Why was ByHeart baby formula recalled?
ByHeart baby formula was recalled after public health agencies, including the FDA and CDC, linked the product to a multistate outbreak of infant botulism caused by Clostridium botulinum contamination. Dozens of infants across 18 states were hospitalized after consuming ByHeart between August and November 2025.
The ByHeart recall includes all of the company’s baby formula products, both powdered and single-serve sticks, and was issued to protect babies from serious health risks such as digestive issues, muscle weakness, and lethargy.
Families who purchased or fed their infants ByHeart formula are urged to stop use immediately and consult a health care professional if any signs of illness appear.
Which ByHeart formula is recalled?
All ByHeart baby formula products were recalled, including powdered formula and single-serve “Anywhere Pack” sticks.
The ByHeart infant formula recall includes ByHeart Whole Nutrition Infant Formula and ByHeart Organic Stage 1 and Stage 2 formulas.
Should I stop using ByHeart formula?
Yes. All ByHeart infant formulas were recalled after officials found botulinum bacteria linked to infant illnesses. You should stop using every ByHeart product right away and switch to a different formula.
What should I do if I still have ByHeart formula?
If you still have ByHeart formula, stop using it immediately and do not feed it to your baby. Contact your health care provider if your child has consumed the formula and shows any signs of illness, such as constipation, weakness, or lethargy.
If you still have the recalled formula at home, follow these steps:
- Take a photo or write down the information on the bottom of the container.
- Keep the container in a safe place and clearly mark it as DO NOT USE.
- If your child develops symptoms, your state health department may ask you to collect the container for testing
- If your child does not develop symptoms after 30 days, throw the container away.
You should also report the recalled product to the FDA or the store where it was purchased. Contact ByHeart for a refund.
What if my child was injured by ByHeart?
If your child was injured by ByHeart formula, seek medical attention immediately to address any health issues, including symptoms of infant botulism. You may also be entitled to compensation for medical expenses, emotional distress, and other harms through a civil lawsuit.
Our team can explain your options and help you take the next steps to protect your child’s rights. Get a free case review now.
