California Alerted CDC of Multistate Infant Botulism Outbreak Linked to ByHeart Infant Formula

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FOR IMMEDIATE RELEASE

November 8, 2025
NR25-017
CONTACT: media@cdph.ca.gov



California Alerted CDC of Multistate Infant Botulism Outbreak Linked to ByHeart Infant Formula

CDPH’s Infant Botulism Treatment and Prevention Program Noted Case Increase, Launching National Investigation

What You Need to Know: The California Department of Public Health is working with other state health departments and the U.S. Centers for Disease Control and Prevention to investigate a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. Preliminary testing of one sample of the formula by the CDPH laboratory suggests the presence of the bacterium that causes botulism. The company has recalled two lots of its product. Consumers with this product should stop using it immediately.

SACRAMENTO – California’s Infant Botulism Treatment and Prevention Program, which developed and provides the only source of infant botulism treatment in the world, noted an increase in infant botulism cases linked to ByHeart powdered infant formula. State public health officials then alerted the U.S. Centers for Disease Control and Prevention (CDC) of a possible outbreak and is working with other state health departments and the CDC to investigate a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. Consumers in possession of this product should stop using it immediately.


On November 8, 2025, ByHeart Inc. recalled two lots of Whole Nutrition Infant Formula:
• Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
• Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)

According to the company’s website, ByHeart Whole Nutrition Infant Formula was sold through their website ByHeart.com and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub.com and others. According to the U.S. Food and Drug Administration (FDA), ByHeart Whole Nutrition Infant Formula makes up less than 1 percent of all infant formula sales in the United States and this outbreak does not create infant formula shortage concerns for parents and caregivers.


Public Health Investigation
CDPH has tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases.

CDC, CDPH, and other state health departments are investigating 13 suspected or confirmed infant botulism cases linked to ByHeart powdered infant formula across 10 states. The affected infants had become ill starting in August 2025. Eight of those cases have since been confirmed as toxin type A botulism, with tests pending for the other cases. The investigation into lots of ByHeart powdered infant formula and potential sources of botulism in infants is ongoing.

What Parents of Infants Need to Know

“Infant Botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.” said Dr. Erica Pan, CDPH Director and State Public Health Officer. “We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”

Parents should report any weakness, difficulty swallowing, or other signs of infant botulism in their infants to healthcare providers immediately. Healthcare providers should report suspected cases of infant botulism to their local health department immediately to facilitate investigation, testing and timely treatment if indicated. If parents note symptoms after an infant has consumed formula, they should record the information on the package including brand and lot number, if still available. Do not discard the product prior checking with your local health department. Typical signs and symptoms of Infant botulism often begin with:

• Constipation
• Difficulty feeding (sucking and swallowing)
• Poor head control
• A weak and altered cry
• Diminished facial expression
• Other signs of muscle weakness

What CDPH is Doing to Protect Californians

CDPH is working closely with the CDC, FDA, and other state health departments to identify and track cases of infant botulism, as well as test suspected product in California at the state’s public health lab.

The antitoxin BabyBIG is the only FDA-approved treatment for infant botulism. CDPH led the development of BabyBIG in the 1990’s, securing FDA approval to produce the life-saving drug in 2003, and remains the only source of BabyBIG in the world. BabyBIG has been shown to reduce the length of hospital stays and treatment costs for infants with botulism and remains the standard first-line therapy for infant botulism.

Physicians with a suspected case of infant botulism may reach California’s Infant Botulism Treatment and Prevention Program at (510) 231-7600 at any time. Parents with concerns or questions about suspected infant botulism should seek medical advice immediately.

Infant Botulism

Infant botulism is the form of botulism which results when swallowed spores of a particular bacterium (Clostridium botulinum) colonize a baby's large intestine and produce botulinum toxin in it. Botulinum toxin causes weakness and loss of muscle tone because it blocks the nerve ending's ability to communicate with muscles. If left untreated, the condition can lead to respiratory failure and even death.



Resources for More Information

• CDPH Infant Botulism Treatment and Prevention Program
• CDPH Frequently Asked Questions about Infant Botulism
• Outbreak Investigation of Infant Botulism: Infant Formula (CDC November 2025)
• Infant Botulism Outbreak Linked to Infant Formula, (FDA November 2025)

www.cdph.ca.gov

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November 8, 2025
Health officials announce case of infant botulism in RI

PROVIDENCE, R.I. (WPRI) — The Rhode Island Department of Health (RIDOH) is urging families to be alert about a certain brand of infant formula after a baby recently contracted infant botulism.

State health officials said the child, who is recovering, was hospitalized after first experiencing symptoms on Oct. 24 and a diagnosis was given Friday.

The baby consumed ByHeart Whole Nutrition Infant Formula that was bough online, according to RIDOH

https://www.yahoo.com/news/articles/health-officials-announce-case-infant-213406100.html

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NYS DOH warns of ByHeart baby formula recall, cases of botulism reported in other states

Posted: Nov 8, 2025 / 07:04 PM EST
Updated: Nov 8, 2025 / 07:15 PM EST

ROCHESTER, N.Y. – The New York State Department of Health has issued a Health Advisory Notice to parents and caregivers following the recall of infant formula due to reports of botulism.

The brand ByHeart recalled specific lots of powdered infant formula after 13 cases of infant botulism, reportedly linked to the product, were confirmed in 10 states outside of New York.

While New York is not listed among the states where contaminated product was reported, the Department of Health is advising those who have purchased the formula to discontinue use and refer to the FDA website for information about the specific product recall.

continued: https://www.rochesterfirst.com/news/...-other-states/

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• Outbreak of Infant Botulism Linked to ByHeart Infant Formula
  
  
  CDPH/Health Advisory - November 11, 2025 - The California Department of Public Health, the Center for Disease Control and Prevent (CDC) and multiple other statesare investigating a large, multi-state outbreak, of infant botulism linked to at least two lots of ByHeart Whole nutrition infant formula. This is the first outbreak associated with powdered infant formula. As of November 10, 2025, fifteen infants with confirmed or suspected infant botulism and recent exposure to ByHeart infant formula have been identified withtwo in California and 13 in eleven other states including Arizona, Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington, Kentucky, and North Carolina. Laboratory confirmation for some cases is ongoing. All infants were hospitalized and all received treatment (BabyBIG ^®).There have been no deaths. California’s Infant Botulism Treatment and Prevention Program noted an increase in infant botulism cases that had a common product exposure. The manufacturer has expanded their voluntary recall to all ByHeart formula nationwide - this includes both cans and single-serve Anywhere Pack™ sticks.

https://www.cdph.ca.gov/Programs/OPA...HAN/CAHAN.aspx

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Source: https://www.cdc.gov/botulism/outbrea...stigation.html

nvestigation Update: Infant Botulism Outbreak, November 2025






For Everyone

Nov. 11, 2025 Key points


CDC, public health officials in several states, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and the U.S. Food and Drug Administration, are investigating a multistate outbreak of infant botulism linked to infant formula. Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.









Investigation details

CDC, public health and regulatory officials in several states, the Infant Botulism Treatment and Prevention Program (IBTPP), and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of infant botulism.
Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum and has made infants sick.

Epidemiologic data

Since the last update on November 8, 2025, two new cases from two new states have been added to this investigation: Kentucky and North Carolina. Both cases were hospitalized and treated with BabyBIG®.
As of November 10, 2025, this outbreak includes 15 infants with suspected or confirmed infant botulism from 12 states (see map). Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025 (see timeline). All 15 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female.
State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.
According to information shared by IBTPP, since August 1, 2025, through November 10, 2025, 84 infants nationwide have received BabyBIG® treatment. Among them, 36 (43%) had any powdered infant formula exposure. Notably, more than 40% (15) consumed ByHeart Whole Nutrition infant formula. This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given FDA's data that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants at this time.

Laboratory and traceback data

Officials in several states have collected leftover infant formula for testing. Preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional product testing by states, CDC, and FDA is ongoing with results expected in the coming weeks.
Public health actions

CDC and FDA are concerned that other lots of ByHeart Whole Nutrition infant may be contaminated and are making infants sick with infant botulism. Parents and caregivers have reported feeding infants in this outbreak different lots of ByHeart infant formula that were not included in the company's initial recall on November 8, 2025. Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately.


Previous updates


Epidemiologic Data

As of November 8, 2025, 13 infants with suspected or confirmed infant botulism have been reported from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from mid-August to November 2025. All 13 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. Infants ranged in age from 16 to 157 days.
State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All 13 (100%) reported feeding ByHeart Whole Nutrition infant formula.
Laboratory and traceback data

Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available but expected in the coming weeks.
Public Health Actions

FDA has been in contact with the firm and has recommended the firm conduct a voluntary recall due to the number of cases, severity of illness, and the strong epidemiological signal. Today, ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by sick infants. FDA is continuing to work with the firm to ensure all potentially impacted products are removed from the market. FDA's investigation is ongoing to determine the point of contamination and if any additional products are impacted.

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Infant Botulism Outbreak Linked to Infant Formula, November 2025

NOV. 14, 2025
KEY POINTS
Investigation status: Open
Recall issued: Yes

CDC, public health officials in several states, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and the U.S. Food and Drug Administration, are investigating a multistate outbreak of infant botulism linked to infant formula. Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.



FAST FACTS

• Cases: 23 (8 new)
• Hospitalizations: 23 (8 new)
• Deaths: 0
• States: 13 (1 new)

ON THIS PAGE

• Recalled infant formula
• What you should do
• What businesses should do
• What clinicians should do
• Symptoms
• See also

continued: https://www.cdc.gov/botulism/outbrea...025/index.html

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Source: https://www.cdc.gov/botulism/outbrea...025/index.html


Infant Botulism Outbreak Linked to Infant Formula, November 2025
For Everyone
Nov. 19, 2025
Key points
Investigation status: Open
Recall issued: Yes

CDC, public health officials in several states, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and the U.S. Food and Drug Administration, are investigating a multistate outbreak of infant botulism linked to infant formula. Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.
Fast Facts

Cases: 31 (8 new)
Hospitalizations: 31 (8 new)
Deaths: 0
States: 15 (2 new)



Recalled infant formula

On November 11, 2025, ByHeart Inc. recalled all infant formula products.

Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes:

All lot numbers
All sizes of cans and single serve packets

ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
What you should do

Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
If possible, take a picture or record the lot number and best by date.
If you have leftover ByHeart powdered formula, label it "DO NOT USE" and keep it stored in a safe place for at least a month.
If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.

Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.

Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
Poor feeding
Loss of head control
Difficulty swallowing
Decreased facial expression
Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.

California Department of Public Health has a public hotline to support caregivers with concerns about this outbreak and infant botulism.
Available Monday to Sunday, 7 a.m. to 11 p.m. Pacific Standard Time
1-833-398-2022

What businesses should do

Do not sell or use recalled ByHeart Whole Nutrition infant formula.
Wash and sanitize items and surfaces that may have touched recalled formula.

What clinicians should do

Initial diagnosis of infant botulism is based on clinical symptoms.
Consultation with the Infant Botulism Treatment and Prevention Program is available for suspected cases. If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24 hours a day, 7 days a week.
If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.

For Health Care Providers
Clinical Overview of Infant Botulism
Symptoms

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing.
If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.

Keep Reading
About Botulism

See also FDA: Outbreak Investigation of Infant Botulism – Infant Formula

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Source: https://www.cdc.gov/botulism/outbrea...025/index.html


Infant Botulism Outbreak Linked to Infant Formula, November 2025
For Everyone
Nov. 26, 2025
Español
Key points
Investigation status: Open
Recall issued: Yes

CDC, public health officials in several states, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and the U.S. Food and Drug Administration, are investigating a multistate outbreak of infant botulism linked to infant formula. Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.
Fast Facts

Cases: 37 (6 new)
Hospitalizations: 37 (6 new)
Deaths: 0
States: 17 (2 new)


Recalled infant formula

On November 11, 2025, ByHeart Inc. recalled all infant formula products.

Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes:

All lot numbers
All sizes of cans and single serve packets

ByHeart Whole Nutrition Infant Formula was available for sale online and at major retailers nationwide...

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CIDRAP
Today at 1:23 p.m.
Quick takes: More infant botulism in US, avian flu in Indiana

• According to the latest update from the Centers for Disease Control and Prevention (CDC), there are now 37 US infants sickened with botulism in a multistate outbreak tied to ByHeart infant powder formula, with six new infections. Seventeen states now report cases, two more than the previous update on November 20. All 37 infants have required hospitalization, with no death reported. The CDC urged parents and caregivers to stop using any ByHeart Whole Nutrition infant formula immediately.

• The US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) published several new commercial poultry detections over the past week, including four outbreaks in Indiana’s LaGrange County, which has been the epicenter of bird flu activity in recent weeks. LaGrange detections included 73,900 birds at four facilities. In Wayne County, North Carolina, two major commercial turkey farms were also hit, involving 17,800 birds in total. In the past 30 days 95 flocks have had confirmed outbreaks, including 43 commercial flocks. In total, 184 million birds have been affected since the outbreak began in February 2022.

https://www.cidrap.umn.edu/botulism/...an-flu-indiana