FDA and CDC Investigate Infant Botulism Outbreak - Company Recalls Baby Formula (FDA Update 11/11/2025)

The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 15 infant botulism illnesses from 12 states (as of the 11/11/25 update).

A few important points to make

• Infant botulism occurs when infants, having yet to establish a stable colonization of their intestinal tract, consume food containing Clostridium botulinum spores.  These spores grow in anaerobic conditions in the intestines, and without a significant competing formula, multiply.  As they grow, they produce botulinum toxin which is absorbed into the bloodstream of the infant.  This toxin is a neurotoxin, which impacts neurotransmission to the autonomic nervous system.
• Infant formula, historically, has not been a known source for infant botulism.  However,  spores can be found in pasteurized milk as well as dried dairy products; this occurring generally through poor sanitary practices.  
• FDA stated that there are 84 cases reported since August 2025.  Only 15 of those cases have reported using this specific formula.  FDA states "According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given 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."
• "As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism"
• The company initially only recalled two lots of formula.  However, at FDA's request, the company expanded this recall to include all product.

Case Counts

Total Illnesses: 15
Hospitalizations: 15
Deaths: 0
Last Illness Onset: November 10, 2025
States with Cases: AZ, CA, IL, KY, MN, NC, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide

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.

Recall - ByHeart, Inc. initially recalled two lots of ByHeart Whole Nutrition Infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by the infants.  FDA requested and the company agreed to recall all product sold nationwide.

From FDA According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given 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.

Ingredients (company website)
https://byheart.com/products/whole-nutrition-formula

Ingredients: organic whole milk*, lactose, organic vegetable oils (organic high oleic sunflower, organic low erucic rapeseed, organic coconut, organic sunflower), organic galactooligosaccharides°, organic lactose, alpha-lactalbumin** whey protein, whey protein hydrolysate, less than 1%: lactoferrin***, dha algal oil⁸ (schizochytrium), mortierella alpina oil¥, vitamin a palmitate, vitamin d3, vitamin e acetate, vitamin k1, thiamine hydrochloride, riboflavin, vitamin b6 hydrochloride, vitamin b12, niacinamide, calcium pantothenate, folic acid, biotin, ascorbic acid, mixed tocopherols, ascorbyl palmitate, l-carnitine, inositol, calcium phosphate, sodium citrate, calcium carbonate, potassium citrate, ferrous sulfate, potassium chloride, magnesium phosphate, calcium chloride, zinc sulfate, cupric sulfate, manganese sulfate, potassium iodide, sodium selenate, potassium bicarbonate, choline chloride.

Contains: milk

Spores of Clostridium botulinum in Dried Dairy Products

https://fri.wisc.edu/files/Briefs_File/2022-10-06_1854_FRI_NewsAlert_Cbot_WheyProtein_28Aug2013.pdf

M. Ellin Doyle and Kathleen Glass

Food Research Institute

University of Wisconsin–Madison, Madison WI 53706

"Spores are known to survive milk pasteurization and other similar thermal processes. Therefore, populations of spores in dried milk products should be minimized through use of good quality milk, temperature control, sanitation of equipment and processing plants, and potentially other processing techniques. The International Commission on Microbiological Specifications for Foods does not recommend routine testing of milk products for Clostridium botulinum spores, but testing for other microbes, such as sulfite-reducing clostridia (limit 100 cfu/g) may be useful as indicators of process control and sanitation. "

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025

Occurrence of human pathogenic Clostridium botulinum among healthy dairy animals: an emerging public health hazard

https://pmc.ncbi.nlm.nih.gov/articles/PMC4870025/

Current Update

November 11, 2025

The FDA and CDC, in collaboration with CDPH IBTPP, and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple 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 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. All 15 infants were hospitalized. No deaths have been reported to date. 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 the 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 treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given 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.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed 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 rule out the presence of the bacteria in the product. 

FDA has been in contact with the firm and has requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. This advisory will be updated as additional information becomes available.

FDA’s investigation is ongoing to determine the point of contamination. This advisory will be updated as information becomes available.   

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025

Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
Do not use certain lots of ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.

Product: Certain lots of ByHeart Whole Nutrition Infant Formula:
Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
The lot code and “Use by” date are located on the bottom of the infant formula can.

ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.

Symptoms of Infant botulism

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

Stores affected
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
Status  Ongoing

Recommendation

Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.

Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.

If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.

Current Update
November 8, 2025

The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington. Laboratory confirmation for some cases is ongoing. There are no deaths reported at this time. The CDPH IBTPP reported an increase in number of botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 13 cases included in this outbreak are reported to have consumed ByHeart- brand powdered infant formula. 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.

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 the infants. FDA is continuing to work with the firm to ensure all potentially impacted product is removed from the market.

FDA’s investigation is ongoing to determine the point of contamination and if any additional products are impacted. This advisory will be updated as information becomes available.

Case Counts
Total Illnesses: 13
Hospitalizations: 13
Deaths: 0
Last Illness Onset: November 2025
States with Cases: AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide

https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/

Infant Botulism Outbreak Linked to Infant Formula, November 2025

Key points

Investigation status: Open

Recall issued: Yes

CDC and public health officials in several states, the Infant Botulism Treatment and Prevention Program, and FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula. Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby's large intestine and make toxin in it. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone.

Fast Facts
Cases: 13
Hospitalizations: 13
Deaths: 0
States: 10
Recalled food

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")

ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide. FDA reports that ByHeart Whole Nutrition Infant Formula makes up an estimated 1% of all infant formula sales in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.

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.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-broadens-voluntary-recall-while-investigation-continues
ByHeart Broadens Voluntary Recall While Investigation Continues

Summary

Company Announcement Date:  November 11, 2025

FDA Publish Date: November 11, 2025

Product Type: Food & Beverages

Reason for Announcement:  Potential Foodborne Illness – Clostridium botulinum

Company Name:  ByHeart Inc.

Brand Name: ByHeart

Product Description:  Whole Nutrition Infant formula 24 oz cans and 0.6oz packets

Company Announcement

[New York, NY] – ByHeart a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin. This action underscores ByHeart’s core mission: protecting babies above all else.

“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Mia Funt, Co-Founder and President of ByHeart. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.

While the FDA is awaiting confirmed results of its testing, ByHeart is taking proactive steps to do all it can to protect families. The company is actively:

Recalling all product from the market while the FDA’s comprehensive investigation seeks to identify a root cause of the broader outbreak

Testing every batch of formula with an independent third-party laboratory—a process which has already begun

Providing FDA and the California Department of Public Health (CDPH) full access to our facilities and unopened cans to conduct testing without restriction

Sharing results from both regulatory and independent testing publicly as they become available

Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possible respiratory arrest. If your child is experiencing any of these symptoms, please seek medical attention immediately.

The FDA and CDC have been conducting a broader investigation into a spike of 84 infant botulism cases that started in August. Once ByHeart was alerted on November 7, 2025, the company acted decisively. The results of the FDA’s investigation into the broader cases will help inform any additional steps as our own investigation continues.

What Consumers Should Do:

Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ should immediately discontinue use and dispose of the product.

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. To report an illness or adverse event, you can:

Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.

Complete an electronic Voluntary MedWatch form online.

Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

If any parents have questions please contact our experts at hello@byheart.com. For more information visit byheart.com External Link Disclaimeror call 1 (833) 429-4327 We are available 24/7.

Media Contact:

ByHeart Public Relations - press@byheart.com

Product Details for Voluntary Recall:

The voluntary recall now applies to all batches of ByHeart Whole Nutrition Infant Formula cans and all Anywhere Packs:

Can UPC: 85004496800

Anywhere Pack (™) UPC: 85004496802

Product Image:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/response-broader-fda-investigation-byheart-initiates-voluntary-recall-two-batches-infant-formula
In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula
Summary
Company Announcement Date:  November 08, 2025
FDA Publish Date:  November 08, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness – Clostridium botulinum
Company Name:  ByHeart Inc.
Brand Name:  ByHeart
Product Description:  Whole Nutrition Infant formula

Company Announcement

[New York, NY] – ByHeartExternal Link Disclaimer, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism.

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

The FDA has an ongoing investigation of infant botulism among babies in the U.S.

The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.

ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.

ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point. The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.

ByHeart adheres to the highest standards of Global and U.S. recommendations for product testing and safety. No ByHeart product has tested positive for any contaminants.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, Co-Founder and President. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”




Product Details for Voluntary Recall:




The voluntary recall applies to the following two batches of ByHeart infant formula:




Batch Code: 251261P2, Use by: 01 Dec 2026

Batch Code: 251131P2, Use by: 01 Dec 2026

UPC: 5004496800

Product Image : See below

The batch code and use by can be found on the bottom of the can.




No other ByHeart batches are impacted by this voluntary recall.




What Consumers Should Do:




Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product. If you’ve discarded any formula from the following batches, ByHeart will replace those cans at no cost.




If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. To report an illness or adverse event, you can:




Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.

Complete an electronic Voluntary MedWatch form online.

Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

If any parents have questions please contact our experts at hello@byheart.com. For more information visit byheart.comExternal Link Disclaimer or call 1 (833) 429 - 4327 We are available 24/7.