Updates:
Botulism outbreak linked to infant formula expands; sickens 51 babies across 19 states Stephanie Weaver, December 10, 2025 Live Fox Now.
Capitalising on Trump’s Make America Healthy Again agenda, the new US company ByHeart has been promoting its infant formulas direct to consumers via global platforms such as Amazon, claiming its products are pure, healthy, “filled with ingredients backed by breast milk science in every scoop” and have undergone ‘rigorous testing going above and beyond what is required’ Through such marketing ByHeart’s formula market has grown fast and spread to Canada, Africa, the Arab world, Asia and Latin America.
The ByHeart story is a lesson in deception. The U.S. Food and Drug Administration (FDA) has investigated ByHeart factories since its launch in 2022, and has found multiple safety violations, leaking roof, mold in a water tank, 2,500 dead flies – enough to raise an Official Action Indicated (OAI) red flag, its highest tier of concern. ByHeart’s infant formula has been identified as the cause of at least 39 cases of potentially deadly infant botulism in 18 US states with a further 70 infants under investigation. All infants were hospitalised.
ByHeart says that it has recalled the products and admits all could be contaminated. However, the products are still onsite in some stores and what about online sales outside the US? The single treatment for infants is only available in the US on ‘a case-by-case evaluation basis.’
IBFAN is calling for a global recall, mandatory reporting of infections, a revision of Codex and WHO’s Food Safety Guidelines and a new World Health Assembly Resolution – calling on all governments to urgently implement the International Code..
Summary of ByHeart’s Contamination problems
In 2022 the FDA led an investigation into ByHeart because of suspected Cronobacter sakazakii contamination.7 ByHeart’s admission that a batch of PIF had tested positive for Cronobacter led to the recall of five batches in December 2022.8
In August 2023 the FDA warned ByHeart: “You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment, as required by 21 C.F.R. 106.55(a).” 9
December 2023 the FDA raised an Official Action Indicated (OAI) red flag, its highest tier of concern after finding multiple safety violations in ByHeart’s Pennsylvania factory, including a leaking roof, mold in a water tank and 2,500 dead flies in a food production area.10 11
November 2025: Dr. Erica Pan, a leading public health expert, noted an increase of infant botulism cases from August 1st. Dr. Pan said that the number of infected infants who had consumed ByHeart formula jumped out at her, because the company’s sales account for only about 1 percent of the national formula market. “So that was a very disproportionate, very concerning signal of what’s going on here”. The FDA investigated ByHeart’s facilities in Allerton, Iowa and Portland, Oregon. The FDA found that ByHeart’s Pennsylvania factory violated its own rules for maintaining the temperatures needed to eliminate bacteria from the formula before it was sent for packaging. ByHeart also failed to report variations in temperature to a supervisor before the formula was sent out to be fed to its infant customers.12
Congresswoman Rosa DeLauro 13 from Connecticut’s Third Congressional District sent a letter to FDA Administrator Marty Makary, demanding that all inspection records of the company’s infant formula manufacturing factories be released to Congress. 14 ByHeart initiated a nationwide recall of all its formulas following the outbreaks but in December, the products are found to be still on sale in some stores.15
Infant botulism must be treated as quickly as possible after symptoms appear
Clostridium botulinum is an anaerobic spore forming bacterium which produces the toxin botulinum, a neuro-toxin, attacking nerve function causing paralysis. Botulism is potentially deadly and must be treated as quickly as possible. Botulism Immune Globulin (referred to as BabyBig) administered intravenously is the single treatment for infants under one year of age and is only available in the US. Access to the BabyBig treatment outside of the US is available only on ‘a case-by-case evaluation basis.’ International requests must go through an onerous process requiring the affected infant’s attending physician to contact an on-call BabyBig physician for approval; after which a letter of authorization from the importing country’s Medicine Regulatory Authority must be issued; payment made; customs cleared; all with a required international courier account and more. Needless to say, access to treatment for infants diagnosed with botulism outside of the US, is likely to be a costly and time consuming process that will be unavailable for the many and too late for an effective treatment.
Why Breastfeeding is so important. “Breastfeeding provides essential nutrition for infants and young children. It makes an irreplaceable contribution to their growth and development. It protects infants from respiratory infections, diarrhoeal diseases, and other potentially life-threatening ailments. Protecting and supporting breastfeeding is recognized as a critical component of securing children’s inalienable right to survival, development and the highest attainable standard of health. Exclusive breastfeeding has the single largest impact on child mortality of any preventive intervention. Globally, poor breastfeeding practices, including not breastfeeding exclusively, contribute to an estimated 11.6% of mortality in children under five years of age. 24. Breastfeeding also has health benefits for the mother and can reduce the mother’s risk of breast and ovarian cancer, type 2 diabetes, and high blood pressure.25
Legal Action
Currently, two families whose infants contracted infantile botulism after consuming ByHeart PIF are suing the company, alleging that the recalled formula was defective and that ByHeart was negligent in producing and in selling it. These families are seeking financial compensation for medical bills, emotional distress, and other damages. It is likely that more infants will contract botulism and more families may initiate lawsuits, with the potential of nationwide litigation, similar to the necrotizing enterocolitis (NEC) case. The Brazilian sanitary authority (ANVISA) has prohibited the importation and sale of ByHeart powdered formula 720 ml in Brazil. INFOSAN, the joint FAO/WHO network of the national food control authorities, issued a global alert warning about this issue on 19 November to all 190 INFOSAN food safety authority members and updates are being provided to INFOSAN members as new information becomes available. The FDA has put out warnings to a number of countries, but there has been no systematic global mandatory recall or warning system as yet. E-commerce makes the importation of individual orders much harder to trace.
Conclusion. This outbreak highlights again systemic failures in PIF production surveillance, regulatory oversight, recall systems and crisis communication, that are exacerbated by commercial promotion globally online. PIF is NOT sterile; it requires strict manufacturing controls, transparent testing and rapid warning and support for families. IBFAN calls on ByHeart to cooperate with the FDA, State Health Departments and independent experts.
To prevent repeated crises that leave large numbers of infants vulnerable to illness and death from contamination or from the growing shocks that disrupt formula supply chains, reliance on formula must be reduced and breastfeeding rates protected and increased through full implementation of the International Code. The US Government must act now to ensure that ByHeart and all US based companies are required to follow the International Code, not only within the United States but also with regard to exports to other countries.
Footnotes
1
ANSES (the French Agency for Food, Environmental and Occupational Health & Safety) and FDA (The US Food & Drug Administration) refer to ‘intestinal toxaemia botulism’ “Because their intestinal flora is not fully formed or fully functional, infants under the age of 12 months are prone to intestinal toxaemia botulism. This form is rare in France, but it is the most common form of botulism in the United States.” https://www.anses.fr/en/content/botulism-how-can-you-prevent-it.
2
More infants sick in outbreak traced to ByHeart formula. 3 December 2025.
Food Safety News https://tinyurl.com/mrxkbjz23
3
More than 100 babies have received treatment for botulism in relation to ByHeart formula outbreak By Coral Beach on November 25, 2025 #
4
ByHeart says all of its products likely contaminated with Clostridium botulinum Food Safety News, Coral Beach on November 26, 2025https://www.foodsafetynews.com/2025/11/byheart-says-all-of-its-products-likely-contaminated-with-clostridium-botulinum/
5
Such as About National Notifiable Diseases Surveillance System | National Notifiable Diseases Surveillance system (NNDSS) | CDC https://www.cdc.gov/nndss/about/index.html
6
ByHeart Infant Formula went to 21 Countries. Are infants ill? Are they getting the BabyBIG botulism anti-toxin? Bill Marler, Nov 29, 2025
https://www.marlerblog.com/case-news/byheart-infant-formula-went-to-21-countries-are-infants-ill-are-they-getting-the-babybig-botulism-anti-toxin/
7
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/byheart-inc-653854-08302023#
8
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/byheart-inc-653854-08302023#
9
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/byheart-inc-653854-08302023#
10
https://www.nytimes.com/2025/11/13/health/infant-formula-botulism.html#
11
https://www.foodsafetynews.com/2025/11/inspectors-found-multiple-problems-at-byheart-infant-formula-production-plants/?utm_source=daily.foodsafetynews.com&utm_medium=newsletter&utm_campaign=byheart-infant-formula-plant-violations-exposed-moringa-powder-salmonella-recall-expands
12
https://www.nytimes.com/2025/11/13/health/infant-formula-botulism.html#
13
https://delauro.house.gov/about-rosa
14
https://delauro.house.gov/sites/evo-subsites/delauro.house.gov/files/evo-media-document/letter-from-ranking-member-delauro-11.14.25.pdf
15
FDA: Recalled Baby Formula that sickened 39 babies with infant Botulism is still on some store shelves. 3rd Dec 2025 https://www.fox13news.com/news/fda-recalled-baby-formula-infant-botulism-still-store-shelves
16
Code of Hygienic Practice on Powdered Formulae for Infants and Young Children CAC/RCP 66/2008
17
Codex Code of Ethics for International Trade in Food
18
https://www.who.int/publications/i/item/9241562218#.
19
Nurturing Care Framework in service provision
20
Infant Feeding in Emergency Core Group.
21
https://www.nbcnews.com/news/us-news/families-sue-byheart-two-babies-sickened-infantile-botulism-rcna243773
22
https://abcnews.go.com/US/nutrition-companies-parents-clash-court-cause-infant-intestinal/story?id=111617194
23
Code of Hygienic Practice on Powdered Formulae for Infants and Young Children CAC/RCP 66/2008
24
Global nutrition targets 2030: breastfeeding brief, WHO UNICEF 22.10.2025. https://www.who.int/publications/i/item/B09382
25
US Centres for Disease Control and Prevention. May 2025 https://www.cdc.gov/breastfeeding/features/breastfeeding-benefits.html
The following article is by Rodney Hyde CEO, Grow Organic Baby: How Industry Influence Undermines U.S. Formula Safety Standards and Why Australian and E.U. Baby Formula is Safer: A Comprehensive Study of What Parents Should Know. For parents seeking the safest organic baby formula, the differences between U.S., European, and Australian standards are important to know. December 9, 2025