The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory analyses indicate that ByHeart Whole Nutrition infant formula is the source of this multistate outbreak of infant botulism.

Since the last update on December 10, 2025, reports of cases linked to this outbreak have slowed, and public health officials have not added any new cases to this investigation. Going forward, instead of weekly updates, CDC will provide updates on this outbreak investigation when new information becomes available. FDA will continue to provide investigational updates as needed.

All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks. On December 12, 2025, FDA sent warning letters to four major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. On December 15, 2025, FDA issued a press releaseand reminded industry about its legal duties regarding food recalls under the Federal Food Drug and Cosmetic Act. FDA asked companies to follow best practices when carrying out recalls. This is especially important for recalls involving foods for infants and young children, who are among our most vulnerable populations.

Additional testing by ByHeart, FDA, CDC, and state partners is underway, and results are expected in the coming weeks. Positive sample results for finished product testing will be included and updated in the Sample Results section below.

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

Case Count Map Provided by CDC

CDC case count map with cases in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Road Island, Texas, Virgina, Washington, Wyoming

Case Counts

Total Illnesses: 51 
Hospitalizations: 51
Deaths: 0
Last Illness Onset: December 1, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally

Useful Links

States with illnesses: Arizona 5, California 12, Idaho 2, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 3, North Carolina 2, New Jersey 1, Ohio 1, Oregon 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2 and Wisconsin 1. 

Illnesses occurred from December 2023 through December 2025.

ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and the British Virgin Islands.

CDC case count map with cases in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Road Island, Texas, Virgina, Washington, Wyoming

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula is contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

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. In response, CDC broadened the case definition to include any infant with botulism who was exposed to ByHeart formula at any time since the product’s release in March 2022. As of December 10, 2025, a total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 19 states. 

Previously, case counts included illnesses from August 1, 2025, onward. With the expanded definition, CDC and state partners identified 10 additional cases that occurred from December 2023 through July 2025. At this time, no cases have been identified between March 2022 and December 2023. All 10 are confirmed infant botulism cases with documented exposure to ByHeart formula.

Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from December 24, 2023 to December 1, 2025. All 51 infants were hospitalized. No deaths have been reported to date. The infants range in age from 16 to 264 days and 22 (43%) 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. Fifty-one infants have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

FDA has not received reports of recalled formula being found on store shelves since November 26, 2025. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.

Additional testing by ByHeart, FDA, CDC, and state partners is underway, and results are expected in the coming weeks. Positive sample results for finished product testing will be included and updated in the Sample Results section.

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

Product sampling and testing is being conducted by FDA, CDC, state partners, and ByHeart. Available information on positive samples is included below. This table will be updated as additional results become available or are shared with FDA.

Due to the large number of samples, only positive results are being reported here. The detection of Clostridium botulinum in infant formula is complex, and a negative test result does not rule out the presence of the bacteria in the product.

Parents and caregivers should not use any ByHeart infant formula, regardless of test results.

Sample Collected/Analyzed byProduct Test ResultToxin Type
CDPHOpened container of ByHeart Infant Formula (Batch No. 251131P2)PositiveType A
ByHeartByHeart Infant Formula (Batch/Batches Not Reported)PositiveType A
ByHeartByHeart Infant Formula (Batch/Batches Not Reported)PositiveType A
ByHeartByHeart Infant Formula (Batch/Batches Not Reported)PositiveType A
ByHeartByHeart Infant Formula (Batch/Batches Not Reported)PositiveType A
ByHeartByHeart Infant Formula (Batch/Batches Not Reported)PositiveType A

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue 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, which is causing infant illness in multiple regions of the country.

Since the last update on November 11, 2025, nine new cases and one new state (Michigan) have been added to this investigation. All 9 cases were hospitalized and treated with BabyBIG®. 

As of November 14, 2025, this outbreak includes 24 infants with suspected or confirmed infant botulism from 13 states – Arizona 3, California 3, Illinois 2, Kentucky 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 2, Pennsylvania 1, Rhode Island 1, Texas 3, Washington 2.

Laboratory confirmation for some cases is ongoing. For 22 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 11, 2025 All 23 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. For 22 infants with age and sex information available, they range in age from 16 to 200 days and 10 (45%) are female.

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 an open 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.  

Epidemiologic data

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. 

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.

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.

KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated.

The fish were distributed nationwide through retail stores. The product comes in a clear plastic vacuum packaged bag with a blue label, containing two whole fish inside marked “Product of Kazakhstan”.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by NYS Food Laboratory revealed the product was not properly eviscerated prior to processing.

The sale of uneviscerated fish is prohibited because clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish have been linked to outbreaks of botulism poisoning. Symptoms of botulism include dizziness, blurred or double vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Walker’s Wine Juice LLC of Forestville, NY is recalling its pumpkin juice because it may be contaminated with Botulism. Botulism is a potentially fatal form of food poisoning and can cause the following symptoms: general weakness, dizziness, double-vision, and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Product was distributed via Walker’s Wine Juice retail store in NY. The juice was also distributed directly by Walker’s to a limited number of commercial wineries in the following states: IL, IN, KS, KY, ME, MI, MN, NJ, NY, OH, PA, WI.

Products can be identified as follows:

  • 2.5-gallon bag in box and 5-gallon hot pack are labeled “pumpkin”; All lots are subject to the recall
  • 30-, 60-, and 275-gallon bulk containers are tagged “pumpkin”; All lots are subject to the recall

No illnesses have been reported to date.

The potential contamination was discovered after an inspection by New York State Department of Agriculture and Markets Food Inspectors found that the pumpkin juice pH was too high to be processed per Walker’s “hot fill” schedule process. As a result, it was determined that no adequate kill step was used to address the possibility of microbiological hazards.

Tipp Distributors, Inc., doing business as Novamex, is recalling Jarritos Coconut Water 12-can cartons because the hermetic seal on the lid of the cans may be compromised.

The compromised hermetic seal may affect can integrity and may cause the cans to leak, bloat or allow bacteria, such as Clostridium botulinum, to grow inside the product which could lead to serious illness 

According to the details published online by the Food and Drugs Administration (FDA), the recall was initiated on Nov. 4 and is ongoing.

The recalled product was distributed in Alabama, Arkansas, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin.

Recalled product:

Jarritos Coconut Water 17.5 fl oz cans- 12 cans per carton

  • Product Quantity: 169,438 cases (2,033,256 cans)
  • Code Information: All lot codes

Retailers and consumers should not use, sell, serve or distribute the affected product.

Botulism_rdax_100

The Fresno County Department of Public Health (FCDPH) is actively investigating a suspected multi-person outbreak of botulism, likely related to contaminated food consumed at a family event on June 21st in Caruthers and June 22nd in Clovis, California. The FCDPH is working closely with the California Department of Public Health (CDPH) and the Centers for Disease Control and Prevention (CDC) to identify the specific food source for their illness.

Botulism is a rare but serious illness caused by a toxin produced by Clostridium botulinum and related bacteria, which can attack the body’s nerves, leading to muscle paralysis-particularly of facial nerves, and in severe cases difficulty breathing and even death. People can get botulism by ingesting the toxin through improperly home-canned, preserved, or fermented foods, or though wounds infected with the bacteria. To avoid food-borne botulism, ensure that home-canning and preserving methods follow proper guidelines and that any items to be preserved are thoroughly cleaned of any soil prior to preparing. Botulism cannot be spread from person to person.

“Our local health department is working closely with area hospitals, state, and national health agencies on this outbreak. While the risk to the general population is low, we are actively tracing those who may have consumed the contaminated food to ensure they get timely monitoring and treatment,” says Dr. Rais Vohra, Interim Health Officer for Fresno County. “This is also a good reminder for everyone to maintain safe food handling practices as we prepare for upcoming Independence Day festivities.”

Symptoms of botulism usually begin with weakness and dizziness, followed by blurred vision, drooping eyelids, and difficulty speaking or swallowing. As the illness progresses, it can cause paralysis that starts in the upper body and moves down to the legs. It is important that anyone ill with symptoms of botulism visit a health care provider immediately to be assessed.

The FCDPH is collaborating with the CDPH to ensure that local hospitals are adequately supplied to treat botulism. If you or a family member attended the family event and present with botulism symptoms, call your health care provider or visit your local emergency department as soon as possible. For more information on botulism, visit: Botulism (ca.gov)

The FCDPH is continuing to monitor the situation in collaboration with the CDPH and partner health agencies and will update the media as new details become available.

06/17/2024, Snapchill LLC (Snapchill) of Green Bay, WI is voluntarily recalling all canned coffee products manufactured by the company, within expiration date, because their current process could lead to the growth and production of the deadly toxin, botulinum toxin, in low acid canned foods. Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. Symptoms can begin from six hours to two weeks after eating food that contains botulinum toxin. People experiencing these problems should seek immediate medical attention.

The products were distributed nationwide through various coffee roasters and retail locations, as well as through direct online purchase from Snapchill. The problem was identified when the U.S. Food and Drug Administration (FDA) notified Snapchill that the low acid canned foods process for manufacturing the recalled products was not filed with FDA, as is required by regulation. No illnesses have been reported to-date, and Snapchill is not aware of any instances in which the company’s products contained botulin toxin. Snapchill is working on filing the appropriate notification with FDA.

The products are sold under a range of roaster and brand names, in variety of metal can sizes ranging from 7 oz to 12 oz. The products are identifiable by the language “Produced and distributed by Snapchill LLC” underneath the nutrition facts panel. Some of the products can also be identified by the text “Snapchill Coffee” on the label. The specific products subject to this voluntary recall are listed at the end of this notice.

This voluntary recall is being made with the knowledge of FDA.

CDC, several state and local health departments, and the U.S. Food and Drug Administration (FDA) are investigating reports of harmful reactions among people who received injections of counterfeit or mishandled botulinum toxin (commonly called “Botox”).

As of April 18, 2024, a total of 22 people from 11 states have reported harmful reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas. Harmful reactions occurred on dates ranging from November 4, 2023, to March 31, 2024. States reporting these reactions include California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas, and Washington.

Public health and regulatory officials have found that some people received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.

More information about the counterfeit products, including signs of counterfeit versions, may be found on FDA’s website.

People have reported experiencing

  • Blurry vision and double vision
  • Drooping eyelids
  • Difficulty swallowing
  • Dry mouth
  • Slurred speech
  • Difficulty breathing
  • Fatigue
  • Generalized weakness

Of 20 people with information available, 11 (55%) people were hospitalized and 6 (27%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Of seven people tested for botulism, six people had negative results. Results are pending for one person.

All reports came from people identifying as females, ranging in age from 25 to 59 years, with a median age of 41 years. Twenty (91%) people reported receiving botulinum toxin injections for cosmetic purposes. All people reported receiving these injections from unlicensed or untrained individuals or in non-healthcare settings, including homes and spas.