A significant outbreak of infant botulism has been linked to ByHeart Whole Nutrition infant formula, with 37 cases reported across 17 states as of November 26, 2025.The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are actively investigating the situation, which has resulted in a nationwide recall of all ByHeart formula products.
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doh.wa.govThe outbreak was first identified when the California Department of Public Health (CDPH) noted an increase in infant botulism cases potentially associated with ByHeart formula.Preliminary testing indicated the presence of Clostridium botulinum, the bacterium responsible for the illness, in both opened and unopened containers of the formula.
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cdph.ca.govSymptoms of infant botulism typically begin with constipation, poor feeding, and loss of head control.If untreated, the condition can progress to severe respiratory issues and potentially lead to respiratory arrest.
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fda.govAll 37 infants affected by this outbreak were hospitalized, although no fatalities have been reported to date.
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doh.wa.govThe CDC has confirmed that the illnesses began between August 9 and November 19, 2025.The affected infants range in age from 16 to 264 days, with a notable portion being female.
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fda.govHealth officials are conducting interviews with caregivers to trace the consumption of ByHeart formula prior to the onset of symptoms.
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doh.wa.govIn response to the outbreak, ByHeart has recalled all of its infant formula products, including both cans and single-serve packets.The FDA has reported that the recalled formula was still being found on store shelves in various states, including major retailers such as Walmart, Target, and Kroger.
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fda.govThe agency is collaborating with state partners to ensure that these products are removed from circulation effectively.
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doh.wa.govParents and caregivers are advised to stop using any ByHeart infant formula immediately and to monitor their infants for symptoms of botulism.If symptoms develop, they should seek medical attention without delay.
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fda.govThe CDPH has set up a hotline for concerned parents, available daily from 7 am to 8 pm PST, to provide guidance and support.
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doh.wa.govThe investigation is ongoing, with further testing being conducted to determine the exact source of contamination.
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doh.wa.govThe FDA has also begun releasing inspection reports from ByHeart facilities to shed light on potential lapses in safety protocols.
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fda.govInfant botulism is rare but can be life-threatening.It occurs when infants ingest spores of Clostridium botulinum, which then grow in their intestines and produce toxins.
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vdh.virginia.govThe antitoxin BabyBIG is available as a treatment, and early recognition and intervention are critical for improving outcomes.
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cdph.ca.govAs this situation develops, health officials are urging parents to remain vigilant and to report any suspected cases of infant botulism immediately to local health authorities.
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vdh.virginia.govThe CDC and FDA will continue to provide updates as more information becomes available, emphasizing the importance of public awareness in preventing further cases.
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doh.wa.govIn conclusion, this outbreak highlights the critical need for stringent safety measures in infant food products and the importance of rapid response from health authorities in managing public health crises.
