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.
📰 Source Timeline (9)
Follow how coverage of this story developed over time
December 17, 2025
3:57 AM
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.
December 10, 2025
11:00 PM
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.
8:57 PM
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.
December 03, 2025
10:51 PM
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.
November 25, 2025
5:36 PM
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.
November 19, 2025
8:17 PM
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.
November 11, 2025
2:32 PM
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.
November 10, 2025
10:48 PM
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.