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All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of single-serve formula cans and sticks “anywhere.”
ByHeart infant formula represents approximately 1% of all infant formula sold in the United States and this outbreak is not creating formula shortage concerns for parents and caregivers.
Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which may progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which are diagnosed clinically, may take several weeks to develop after ingesting infant formula.
Affected stores
ByHeart Whole Nutrition infant formula was available for sale online and in-store at major retailers nationwide. The ByHeart Plan may also be available through online marketplaces, but should not be sold or purchased.
Status
In progress
Recommendations
- Parents and caregivers should immediately stop using ByHeart infant formula.
- If your child has consumed ByHeart formula and has symptoms (see below), seek medical attention immediately.
- If your child has consumed ByHeart formula and is currently not experiencing any symptoms, continue to monitor them and seek medical attention if symptoms develop.
- If you still have the formula at home, you must:
- Take a photo or record the information at the bottom of the package.
- Store the container in a safe place and be sure to label this product as DO NOT USE.
- If your child develops symptoms, your state health department may want to collect your container of formula for testing. If your child does not develop any symptoms after 30 days, throw away your containers.
- Retailers must ensure that recalled products are not on store shelves, including products returned by customers.
- Botulism can be fatal, and you should act immediately. If your child has consumed ByHeart Whole Nutrition infant formula and shows signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek medical attention immediately.
- If you are a doctor and suspect that an infant has botulism, immediately call 510-231-7600 for case consultation. Consultations are available 24/7.
Current update
November 14, 2025
The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), the Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate an outbreak of infant botulism in several states. Epidemiological and laboratory data show that ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinum, which causes childhood illness in several areas of the country.
As of November 14, 2025, a total of 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported in 13 states (see map). Laboratory confirmation of some cases is underway. For the 22 cases for which information on illness onset is available, the illnesses began on dates ranging from August 9 to November 11, 2025. All 23 infants were hospitalized. No deaths have been reported to date. For the 22 infants for whom age and sex information is available, they are aged 16 to 200 days and 10 (45%) are girls.
As part of this investigation, authorities in several states collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggested the presence of the bacteria that produces botulinum toxin in an opened can of ByHeart infant formula (Lot 206VABP/251131P2) that was given to an infant with infant botulism. Additional testing is underway and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult and a negative test result does not exclude the presence of the bacteria in the product.
The FDA investigation, including on-site inspections and sample collection, is ongoing to determine the point of contamination. This notice will be updated as information becomes available.
Case count map provided by the CDC
Number of cases
Total illnesses: 23
Hospitalizations: 23
Deaths: 0
Last appearance of the disease: November 11, 2025
State with cases: AZ, CA, CA, IL, KY, MI, MN, NJ, OR, OR, OR, TX, WA
Product distribution: online and nationwide
Product Images
Previous updates
November 11, 2025
The FDA is expanding its recommendation to include all ByHeart infant formula due to the number of sick infants reported to have consumed this product, the identification of additional lot codes, the identification of new suspected cases of infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP).
The FDA and CDC, in collaboration with CDPH IBTPP and state and local partners, are investigating an outbreak of infant botulism in several states. Epidemiological and laboratory data show that ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinumwhich causes childhood illnesses in several regions of the country.
As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported in 12 states (see map). Laboratory confirmation of some cases is underway. For 14 cases for which information on illness onset is available, illnesses began on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For the 14 infants for whom age and sex information is available, they are aged 16 to 157 days and 7 (50%) are girls.
State and local public health officials ask caregivers about the foods infants were fed in the month before they became ill. Fifteen cases of infant botulism were identified who were fed ByHeart Whole Nutrition powdered formula before becoming ill.
According to information shared by IBTPP, between August 1, 2025 and November 10, 2025, 84 infants nationwide received treatment for infant botulism. Of these, 36 (43%) were exposed to powdered infant formula. Notably, more than 40% (15) of infants exposed to powdered infant formula consumed ByHeart Whole Nutrition infant formula. This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially since ByHeart represents approximately 1% of all infant formula sales in the United States. Investigations continue, but have not identified any other brands of infant formula or shared exposures that pose a risk to infants.
As part of this investigation, authorities in several states collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggested the presence of the bacteria that produces botulinum toxin in an opened can of ByHeart infant formula (Lot 206VABP/251131P2) that was given to an infant with infant botulism. Additional testing is underway and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult and a negative test result does not exclude the presence of the bacteria in the product.
The FDA has been in contact with the company and requested an expansion of the recall to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formulas nationwide, including single-serve cans and sticks.
November 8, 2025
The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), the Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 illnesses related to infant botulism in 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington. Laboratory confirmation of some cases is underway. No deaths have been reported at this time. CDPH IBTPP reported an increase in type A botulism infections in infants consuming ByHeart powdered infant formula between August 2025 and November 2025. All 13 cases included in this outbreak were reported to have consumed ByHeart brand powdered infant formula. Authorities in several states have collected leftover infant formula for testing. These tests are in progress and the results are not yet available but expected in the coming weeks.
The FDA has been in contact with the company and recommended a voluntary recall due to the number of cases, severity of illness and strong epidemiological signal. Today, ByHeart, Inc. agreed to initiate a recall of two lots of ByHeart Whole Nutrition infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were allegedly consumed by infants. The FDA continues to work with the company to ensure that all potentially affected products are removed from the market.
Who to contact
Consumers who exhibit symptoms should contact their health care provider to report their symptoms and receive care.
To report a complaint or adverse event (serious illness or allergic reaction),
visit Industry and Consumer Assistance.
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