By Heart Infant Formula tied to Botulism Outbreak grows to 37

We have been retained by 27 families whose infants consumed ByHeart formula. Some of these infants became ill in late 2024 and early to mid 2025.

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.

As of November 26, 2025, a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 17 states –

Arizona 3

California 5

Idaho 1

Illinois 2

Kentucky 1

Massachusetts 2

Maine 1

Michigan 1

Minnesota 2

North Carolina 2

New Jersey 1

Oregon 3

Pennsylvania 1

Rhode Island 1

Texas 8

Washington 2

Wisconsin 1

Laboratory confirmation for some cases is ongoing. For 36 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 19, 2025. All 37 infants were hospitalized. No deaths have been reported to date. For 35 infants with age and sex information available, they range in age from 16 to 264 days and 15 (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. Thirty-seven infants have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Acme, Jewel-Osco, Shaw’s, Star Market, Smith’s, King Sooper’s, Albertson’s, Whole Foods, Wegman’s, and Publix locations. FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country. 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.

FDA’s investigation, including onsite inspections, is ongoing to determine the point of contamination. FDA is releasing the FDA Establishment Inspection Reports (EIRs) and FDA Form 483s, Inspectional Observations from completed inspections previously conducted between 2022 and March 2025 at ByHeart facilities. ByHeart, Inc. is the parent company of three Blendhouse manufacturing facilities in Allerton, Iowa; Portland, Oregon; and Reading, Pennsylvania.

• Blendhouse Allerton: the facility was last inspected in February 2025 and classified Voluntary Action Indicated (VAI), which cited GMP deficiencies
• Blendhouse Portland: the facility was last inspected in March 2025 and classified No Action Indicated (NAI)
• Blendhouse Reading: the facility was last inspected in January 2024 and classified Official Action Indicated (OAI). This facility has not been in operation since September 2023.

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

Case Counts

Total Illnesses: 37 (6 New)
Hospitalizations: 37 (6 New)
Deaths: 0
Last Illness Onset: November 19, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally

Useful Links

• CDC Outbreak Advisory
• Infant Botulism Treatment and Prevention Program
• ByHeart Expanded Recall Announcement
• Food Safety Tips for Retailers and Consumers During an Outbreak
• Food Safety Resources for Produce Shippers and Carriers During a Foodborne Illness Outbreak

Product Images

Sample Results

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.

International Distribution

The ByHeart infant formula recall impacts markets outside the United States. Customer information provided by Amazon shows that a limited quantity of recalled 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.

Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall.

Laboratory confirmation for some cases is ongoing. For 27 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 13, 2025. All 31 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. For 23 infants with age and 24 with sex information available, they range in age from 16 to 200 days and 11 (46%) are female.

What is Botulism?

Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum.[1] Unlike Clostridium perfringens, which requires the ingestion of large numbers of viable cells to cause symptoms, the symptoms of botulism are caused by the ingestion of highly toxic, soluble exotoxins produced by C. botulinum while growing in foods.[2] These rod-shaped bacteria grow best under anaerobic (or, low oxygen), low-salt, and low-acid conditions.[3] Bacterial growth is inhibited by refrigeration below 4° C., heating above 121° C, and high water-activity or acidity.[4] And although the toxin is destroyed by heating to 85° C. for at least five minutes, the spores formed by the bacteria are not inactivated unless the food is heated under high pressure to 121° C. for at least twenty minutes.[5] C. botulinum bacteria and spores are widely distributed in nature, because they are indigenous to soils and waters.[6] They occur in both cultivated and forest soils, bottom sediment of streams, lakes, and coastal waters, in the intestinal tracts of fish and mammals, and in the gills and viscera of crabs and other shellfish.[7]

The incidence of foodborne botulism is extremely low.[8] Nonetheless, the extreme danger posed by the bacteria has required that “intensive surveillance is maintained for botulism cases in the United States, and every case is treated as a public health emergency.”[9] This danger includes a mortality rate of up to 65% when victims are not treated immediately and properly.[10] Most of the botulism events[11] that are reported annually in the United States are associated with home-canned foods that have not been safely processed.[12] Occasionally, though, commercially-processed foods are implicated as the source of a botulism events, including sausages, beef stew, canned vegetables, and seafood products.[13]

Symptoms of Botulism

After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, pass into the bloodstream, and travel to synapses in the nervous system.[14] There, the neurotoxins cause flaccid paralysis by preventing the release of acetylcholine, a neurotransmitter, at neuromuscular junctions, thereby preventing motor-fiber stimulation.[15]The flaccid paralysis progresses symmetrically downward, usually beginning with the eyes and face before moving to the throat, chest, and extremities.[16] When the diaphragm and chest muscles become fully involved, respiration is inhibited and, unless the patient is ventilated, death from asphyxia results.[17]

Classic symptoms of botulism include nausea, vomiting, fatigue, dizziness, double vision, drooping eyelids, slurred speech, difficulty swallowing, dryness of skin, mouth, and throat, lack of fever, muscle weakness, and paralysis.[18] Infants with botulism appear lethargic, feed poorly, are constipated, and have a weak cry and poor muscle tone.[19] Throughout all such symptoms, the victims are fully alert and the results of sensory examination are normal.[20]

In foodborne botulism cases, symptoms usually begin anywhere between 12 and 72 hours after the ingestion of toxin-containing food.[21] Longer incubation periods—up to 10 days—are not unknown, however. The duration of the illness is from 1 to 10 (or more) days, depending on host-resistance, the amount of toxin ingested, and other factors.[22] Full recovery often takes from weeks to months.[23] And, as earlier indicated, mortality rate can be from 30% to 65%, with rates generally lower in European countries than in the United States.[24]

Detection and Treatment of Botulism

Although botulism can be diagnosed based on clinical symptoms, its differentiation from other diseases is often difficult—especially in the absence of other known persons affected by the condition.[25] Once suspected, the most direct and effective way to confirm the diagnosis of botulism in the laboratory is testing for the presence of the botulinum toxin in the serum, stool, or gastric secretions of the patient.[26] The food consumed by the patient can also be tested for the presence of toxins.[27] Currently, the most sensitive and widely used method for the detection of the toxins is the mouse neutralization test, which involves injecting serum into mice and looking for signs of botulism.[28] This test typically takes 48 hours, while the direct culturing of specimens takes 5-7 days.[29] Some cases of botulism may go undiagnosed because symptoms are transient or mild, or are misdiagnosed as Guillain-Barre Syndrome.[30]

If diagnosed early, foodborne botulism can be treated with an antitoxin that blocks the action of toxin circulating in the blood.[31] This can prevent patients from worsening, but recovery still takes many weeks.[32] The mainstay of therapy is supportive treatment in intensive care, and mechanical ventilation in case of respiratory failure, which is common.[33]

Long-Term and Permanent Injury

Although a minority of botulism patients eventually recover their pre-infection health, the majority do not. For those who fully recover, the greatest improvement in muscle strength occurs in the first three months after the acute phase of illness.[34] The outside limit for such improvement appears, however, to be one year.[35] Consequently, physical limitations that still exist beyond the one-year mark are more probably than not permanent. Recovery from acute botulism symptoms may also be followed by persistent psychological dysfunction that may require intervention.[36]

According to a recently-published study that tracked the long-term outcomes of 217 cases of botulism, a large majority of patients reported “significant health, functional, and psychosocial limitations that are likely the consequences of the illness.”[37] These limitations included: fatigue, weakness, dizziness, dry mouth, and difficulty lifting things. The victims also reported difficulty breathing caused by moderate exertions, such as walking or lifting heavy items. They were also more likely to have limitations in vigorous activities, like running or playing sports, climbing up three flights of stairs, or carrying groceries. Summarizing its finding, the study concluded that:

Even several years after acute illness, patients who had botulism were more likely than control subjects to experience fatigue, generalized weakness, dizziness, dry mouth, difficulty lifting things, and difficulty breathing caused by moderate exertion….In addition, patients…reported worse overall psycho-social status than did control subjects, with patients being significantly less likely to report feeling happy, calm and peaceful, or full of pep.[38]

There is, as a result, no question that the damaging effects of botulism are life-long.

____________________

[1] See J. Sobel, et al., Foodborne Botulism in the United States, 1990-2000, Emerging Infectious Diseases, Vol. 10, No. 9, at 1606 (Sept. 2004).

[2] James M. Jay, MODERN FOOD MICROBIOLOGY, 466 (6^th Ed. 2000)

[3] Id. at 469-71; see also Sobel, supra note 2, at 1606.

[4] Sobel, supra note 2, at 1606.

[5] Id.

[6] Jay, supra note 3, at 467-69. See also, generally H. Houschild, Clostridium Botulinum, in FOODBORNE BACTERIAL PATHOGENS, at 112-89 (M. Doyle Ed. 1989)

[7] Jay, supra note 3, at 467-69.

[8] Sobel, supra note 2, at 1607-09; Jay, supra note 3, at 472-76.

[9] Sobel, supra note 2, at 1606-07 (also noting that the CDC maintains a 24-hour clinical consultation and emergency antitoxin release service).

[10] Jay, supra note 3, at 474.

[11] With botulism, the broader term “event” is used to encompass both outbreaks—i.e., two or more cases of botulism caused by a common-source, as well as individual (or sporadic) cases.

[12] Sobel, supra note 2, at 1610; Jay, supra note 3, at 474.

[13] Id.

[14] Thomas P. Bleck, Clostridium botulinum (Botulism), in MANDELL, DOUGLAS AND BENNETT’S PRINCIPLES AND PRACTICE OF INFECTIOUS DISEASE 2543, 2544 (5^th ed. 2000).

[15] Id.; Sobel, supra note 2, at 1606.

[16] Bleck, supra note 15, at 2545; see also BOTULISM FACT SHEET, National Agricultural Bio-Security Center, Kansas State University, online at http://nabc.ksu.edu/content/factsheets/category/Botulism#f26

[17] Bleck, supra note 15, at 2545; Sobel, supra note 2, at 1606.

[18] Sobel, supra note 2, at 1606; Jay, supra note 3, at 474.

[19] Jay, supra note 3, at 476-77.

[20] Sobel, supra note 2, at 1606.

[21] Jay, supra note 3, at 474.

[22] Id.

[23] R. Shapiro, et al., Botulism in the United States: A Clinical and Epidemiologic Review, Ann. Intern. Med. 1998; 129:221-28.

[24] Jay, supra note 3, at 474.

[25] Bleck, supra note 15, at 2546 (noting that “botulism has a limited differential diagnosis”).

[26] Sobel, supra note 2, at 1607; see also FDA/CFSAN Bad Bug Book, Clostridium Botulinum, available at http://vm.cfsan.fda.gov/~mow/chap2.html

[27] Id.

[28] Bleck, supra note 15, at 2546. See also, e.g. MMWWR, supra note 1, at 2 (“CDC detected botulinum toxin Type A by mouse bioassay in the man’s serum sample”).

[29] Bad Bug Book, supra note at 25.

[30] Sobel, supra note 2, at 1606; Shapiro, supra note 23, at 223.

[31] Jay, supra note 3, at 474; Sobel, supra note 2, at 1606.

[32] Id.; Bleck, supra note 15, at 2546-67.

[33] Sobel, supra note 2, at 1606.

[34] Bleck, supra note 15, at 2547. See also P. Wilcox, et al., Recovery of Ventilatory and Upper Airway Muscles and Exercise Performance After Type-A Botulism, Chest, 98:620-26 (1990); J. Mann, et al., Patient Recovery From Type-A Botulism: Morbidity Assessment Following a Large Outbreak, Am. J. Public Health, 71 (3):266-69 (Mar. 1981).

[35] Id.

[36] Bleck, supra note 15, at 2547. See also F. Cohen, et al., Physical and Psychosocial Health Status 3 Years After Catastrophic Illness—Botulism, Issues Mental Health Nurs., 9:387098 (1988)

[37] S. Gottlieb, et al., Long-Term Outcomes of 217 Botulism Cases in the Republic of Georgia, Clin. Infectious Disease, 45: 174-80, at 180 (220&).

[38] Id. at 179.

Botulism: Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Botulismoutbreaks. The Botulism lawyers of Marler Clark have represented thousands of victims of Botulism and other foodborne illness outbreaks and have recovered over $900 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Botulism lawyers have litigated Botulism cases stemming from outbreaks traced to carrot juice, pesto, cheese and chili.

If you or a family member became ill with Botulism after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Botulism attorneys for a free case evaluation.