ByHeart infant botulism outbreak rises to 51 cases across 19 states; all hospitalized
The outbreak of infant botulism linked to ByHeart powdered infant formula has grown to 51 confirmed or suspected cases in 19 states (illness onset Aug. 9–Nov. 19, with CDC’s expanded case definition identifying additional cases back to Dec. 2023–July 2025); all 51 infants were hospitalized and no deaths have been reported. ByHeart has recalled all products after C. botulinum type A was detected in some samples, and FDA, CDC and state agencies are continuing inspections and testing while urging caregivers to stop using and dispose of recalled formula and seek medical care if infants show symptoms.
📌 Key Facts
- As of Dec. 10, 2025, public health authorities report 51 confirmed or suspected infant botulism cases across 19 states; all 51 infants were hospitalized and no deaths have been reported.
- Illness onset dates in the investigation range from Aug. 9 to Nov. 19, 2025; the CDC expanded the case definition and identified 10 additional cases dating back to Dec. 2023–July 2025.
- ByHeart expanded its recall to all products (including Whole Nutrition Infant Formula and Anywhere Pack pouches) on Nov. 11, 2025; the FDA says all ByHeart products are recalled but earlier retail checks found some recalled product still on store shelves, and the agency reported no new shelf reports since Nov. 26, 2025.
- Laboratory testing detected Clostridium botulinum type A in ByHeart formula (5 of 36 samples); California confirmed botulism bacteria in an opened can that had been fed to a sick infant, while no unopened cans have tested positive so far.
- ByHeart produces powdered formula in Allerton, Iowa, and cans/distributes products in Portland, Oregon; the FDA has inspected both facilities and third‑party and agency testing (ByHeart, FDA, CDC and state labs) is ongoing.
- Health officials and the company instruct parents and caregivers to stop using and dispose of recalled ByHeart powdered formula, label any retained product 'DO NOT USE' and keep it for potential testing if symptoms develop, and to contact a health care provider immediately if an infant shows symptoms of botulism.
- State health agencies — including the Minnesota Department of Health, which issued a statewide warning and confirmed Minnesota is among the affected states — conducted retail checks that removed recalled product from some sites and cautioned additional lot numbers could be recalled.
- Earlier in the investigation two specific lots were initially identified (206VABP/251261P2 and 206VABP/251131P2, Use by Dec. 1, 2026), but ByHeart and regulators have since broadened the recall to all lots and warned all products may be contaminated.
📊 Relevant Data
In 2021, there were 181 reported cases of infant botulism in the United States, with a median age of 3 months and no deaths reported.
The overall prevalence of breastfeeding initiation in the US is 84.0%, ranging from 74.5% among mothers identifying as Black to 94.0% among mothers identifying as Japanese.
Disaggregation of Breastfeeding Initiation Rates by Race and Ethnicity — CDC Preventing Chronic Disease
In a 2025 review of global evidence, heavy metals were detected in 63% of infant formulas, with lead detected in 74%, cadmium in 61%, arsenic in 63%, and mercury in 42%.
New review reveals which baby foods carry the highest heavy metal risks — News-Medical.net
From 2000 to 2019, Hispanic infants represented 20.6% of infant botulism cases in the United States, higher than their proportion in the general population, while non-Hispanic Black infants represented 2.8%, lower than their population proportion.
Elevated incidence of infant botulism in a 17-county area of the Mid-Atlantic United States, 2000–2019 — PMC (NCBI)
📰 Sources (8)
- FDA now reports 51 confirmed or suspected infant botulism cases in 19 states, up from 39 cases in 18 states earlier this month.
- Minnesota remains among the affected states; Ohio is newly added.
- All 51 infants were hospitalized; no deaths reported.
- Illness onset dates range from Aug. 9 to Nov. 19; CDC expanded the case definition, identifying 10 additional cases dating back to Dec. 2023–July 2025.
- FDA says it has not received reports of recalled ByHeart formula on store shelves since Nov. 26, 2025, after earlier consumer reports that products were still being sold.
- Parents/caregivers are instructed to stop using and dispose of recalled ByHeart powdered formula; additional testing by ByHeart, FDA, CDC and states is ongoing.
- Outbreak case count has increased to more than 50 infants (previously 39).
- Recall scope has expanded to cover all ByHeart products, not just certain lots of formula.
- FDA now reports 39 confirmed or suspected infant botulism hospitalizations in 18 states linked to ByHeart formula (latest illness Nov. 19).
- Minnesota is among the affected states, per the FDA update.
- FDA says all ByHeart infant formula products have been recalled but some are still being found on store shelves; the agency is working with states and retailers to remove them.
- Lab tests tied to the outbreak detected C. botulinum type A in ByHeart formula (5 of 36 samples).
- ByHeart warned all lots may be contaminated, adding to earlier case counts (31 infants, 15 states).
- FDA and state officials say some recalled ByHeart products remained on store shelves, underscoring ongoing consumer risk.
- Hospitalizations tied to ByHeart infant formula have climbed to at least 31 across 15 states; latest case reported Nov. 13.
- Minnesota conducted 119 retail checks Nov. 13–17 and removed recalled ByHeart products from sale at four sites.
- Investigators in Oregon (9 of 150+ stores) and Arizona also found recalled product still on shelves a week after the nationwide recall.
- FDA has inspected ByHeart facilities in Allerton, IA, and Portland, OR; no inspection results yet.
- California confirmed botulism bacteria in an opened can fed to a sick infant; no unopened cans have tested positive.
- Officials advise consumers to label any ByHeart product 'DO NOT USE' and keep it for a month for potential testing if symptoms develop; California set up a public hotline (833-398-2022).
- Walmart says it blocked sales, removed product, and will refund customers; cans retailed around $42.
- ByHeart expanded its recall to all products (Whole Nutrition Infant Formula and Anywhere Pack pouches) on Nov. 11, 2025.
- At least 15 infants in 12 states have been hospitalized since August after consuming ByHeart formula; no deaths reported.
- FDA says it is investigating 84 infant botulism cases since August; 36 consumed infant formula and more than one-third used ByHeart, which accounts for ~1% of U.S. formula sales.
- California confirmed botulism bacteria in an open can linked to a sick infant; no unopened ByHeart product has tested positive.
- ByHeart produces powder in Allerton, Iowa, and cans/distributes in Portland, Oregon; FDA inspectors were at the Portland site Monday.
- Company instructs parents to immediately discontinue use and dispose of any ByHeart formula; third‑party batch testing is underway.
- Minnesota Department of Health issued a statewide warning tied to the ByHeart infant formula outbreak and confirms Minnesota is among affected states.
- MDH cautions that additional lot numbers could be recalled beyond the two lots already identified.
- Reiterates exact recalled lots (206VABP/251261P2 and 206VABP/251131P2, Use by 01 Dec 2026) and urges parents to contact a health care provider immediately if infants show symptoms.