Baby formula is regulated to make sure it’s safe and provides the right mix of nutrients babies need. But sometimes, formula may be recalled when there is concern about possible contamination or other health risks. When germs get into formula at the factory, for example, it may not smell or look spoiled but can still make babies very sick.
Most baby formula is safe, but it’s important to stay updated on recalls and know what steps to take if one is announced.
Baby formula recalled for botulism concerns
Health officials are looking into a rare type of food poisoning called infant botulism possibly linked to ByHeart Whole Nutrition infant formula. So far, at least 37 babies in 17 states, all under 1 year old, have been diagnosed with botulism. All of them had been fed this formula. The babies were treated in the hospital, and no deaths have been reported.
On November 11, 2025, the company announced a voluntary recall of all of its formula products nationwide. An independent food safety testing firm later found a type of bacteria that causes infant botulism in some of the samples pulled from unopened lots of formula.
The brand was sold online and in stores including Walmart, Kroger, Albertsons, Publix, Target, Whole Foods and others. ByHeart represents about 1% of all infant formula sales in the U.S., so this recall is not expected to cause any shortages of formula.
The ByHeart recall came as the U.S. Food and Drug Administration (FDA) was conducting a wider investigation into rising infant botulism cases. According to the FDA, 84 cases of infant botulism had been reported since August 2025. Most years, there are about 100–200 cases total in the U.S.
What is infant botulism?
Infant botulism is caused by a germ called clostridium botulinum (c. botulinum). This germ makes spores that live in soil and dust. If a baby swallows these spores, their body can turn them into a toxin that affects the nerves.
Infants can also get botulism from other sources, including honey, raw milk (from cows or goats) and homemade baby formula. That’s why you should never feed babies honey before their first birthday, and why raw milk and homemade formula is not safe.
Signs & symptoms of infant botulism
Symptoms of infant botulism can start slowly and get worse over time. Watch for:
If your baby shows any of these signs, especially after using the recalled formula, get medical help right away. Infant botulism can lead to breathing problems and may require a ventilator. With early treatment, most babies recover.
Other germs that can get into formula
Other germs that have prompted past baby formula recalls include:
Cronobacter sakazakii, a type of bacteria that can cause a severe, life-threatening infection called
sepsis. It can also cause meningitis (inflammation around the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability,
temperature changes,
jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements.
Cronobacter infection can also cause bowel damage.
Salmonella bacteria, which can cause stomach and intestinal illness including severe diarrhea, which can quickly cause
dehydration in babies. More severe cases of
Salmonella infection may include a high
fever, aches, headaches, lethargy, a rash and
blood in the urine or stool.
What should I do if my baby's infant formula is recalled?
If your formula is recalled,
immediately stop feeding it to your baby. Check the FDA recalls/safety alert webpage for instructions. You may be required to take the recalled formula to the store for a refund and exchange or call the company to help you. If you are receiving
WIC benefits, you should be able to obtain a different brand of similar formula. But if there is any problem, call your WIC office for advice and assistance.
Do I need to talk to my pediatrician if I switch to a different baby formula?
That is a good idea, but for many formulas you can switch to a similar product made by another company including store brand formulas. Make sure to check the formula cans carefully;
mixing instructions (how much water and formula to add to the bottle) can be different for different formula brands.
Can germs spread in other ways when I'm feeding my baby?
Yes, germs can be found in unclean baby feeding supplies and in the environment, including unclean counter tops. Always follow
good safety practices when preparing formula for your infant.
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