ByHeart infant botulism outbreak rises to 51 cases across 19 states; all hospitalized
Federal officials say the infant botulism outbreak linked to ByHeart formula has grown to 51 confirmed or suspected cases in 19 states — all hospitalized and with no deaths — with illness onset dates from Aug. 9 to Nov. 19 after the CDC expanded its case definition to identify additional cases dating back to Dec. 2023–July 2025. ByHeart has recalled all products, testing has detected C. botulinum type A in some samples, and while officials earlier found recalled cans still on shelves, the FDA reported no new on‑shelf reports after Nov. 26; parents are urged to stop using and dispose of any ByHeart formula and seek medical care if infants show symptoms.
📌 Key Facts
- The outbreak now includes 51 confirmed or suspected infant botulism cases across 19 states; all 51 infants were hospitalized and no deaths have been reported.
- Reported illness onset dates for the current outbreak range from Aug. 9 to Nov. 19; CDC expanded the case definition and identified 10 additional earlier cases dating from Dec. 2023 through July 2025.
- ByHeart expanded its recall to all products (including Whole Nutrition Infant Formula and Anywhere Pack pouches) on Nov. 11; the FDA also lists all ByHeart infant formula products as recalled and parents/caregivers are instructed to stop using and dispose of recalled product.
- Laboratory testing has detected Clostridium botulinum type A linked to the outbreak (5 of 36 tested samples), and California confirmed botulism bacteria in an opened can that had been fed to a sick infant; no unopened cans have tested positive to date.
- ByHeart’s powdered formula is produced in Allerton, Iowa, and cans/distribution occur in Portland, Oregon; FDA has inspected both facilities (inspectors were at the Portland site), but inspection results have not been released.
- Recalled ByHeart products were found on store shelves after the recall in multiple states (including Minnesota, Oregon and Arizona); officials and retailers have removed product in some locations (Minnesota removed product from four sites after 119 retail checks; Walmart blocked sales and issued refunds), but the FDA has reported slow retailer compliance with removals.
- State health agencies (including the Minnesota Department of Health) issued warnings and urged vigilance — advising consumers to label recalled product 'DO NOT USE,' keep it available for possible testing, contact a health care provider if infants show symptoms, and noting that additional lot numbers could be recalled; California set up a public hotline (833-398-2022).
- Federal and state agencies continue investigating and testing: the FDA has investigated dozens of infant botulism cases since August (84 total under review), with 36 cases involving infant formula and more than one-third of those reporting ByHeart use; third‑party batch testing and additional testing by ByHeart, FDA, CDC and states remain ongoing.
📰 Sources (9)
Major retailers slow to remove recalled infant formula from shelves, FDA says
New information:
- FDA reports slow retailer compliance in removing recalled infant formula tied to the outbreak.
- Consumers are advised to check lot numbers and not use any recalled product that remains on shelves or in homes.
- The update highlights continued retail availability risks despite the recall and outbreak warnings.
Botulism outbreak linked to infant formula expands; sickens 51 babies across 19 states
New information:
- 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.
Botulism outbreak sickens more than 50 babies and expands to all ByHeart products
New information:
- 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: Recalled baby formula that sickened 39 babies with infant botulism is still on some store shelves
New information:
- 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.
ByHeart baby formula from all lots may be contaminated with botulism bacteria, tests show
New information:
- 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.
As infant botulism cases climb to 31, recalled ByHeart baby formula is still on some store shelves
New information:
- 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 recalls all baby formula sold nationwide as infant botulism outbreak grows
New information:
- 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 warns of infant botulism case in MN linked to formula
New information:
- 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.