FDA: ByHeart infant-botulism cases rise to 39; recalled formula still on some shelves
The FDA says 39 confirmed or suspected infant botulism hospitalizations in 18 states have been linked to ByHeart infant formula, which was recalled nationwide after lab tests detected C. botulinum type A in some samples (including an opened can in California); no unopened cans have tested positive and no deaths have been reported. Despite the recall, investigators have still found ByHeart products on store shelves in multiple states, and federal and state officials are urging parents to stop using the formula, keep samples for possible testing, contact health care providers if infants show symptoms, and are working with retailers to remove remaining stock.
📌 Key Facts
- The FDA reports 39 confirmed or suspected infant botulism hospitalizations in 18 states linked to ByHeart infant formula (latest illness reported Nov. 19); Minnesota is among the affected states.
- ByHeart expanded its recall to all infant formula products (including Whole Nutrition Infant Formula and Anywhere Pack pouches) on Nov. 11, and the FDA says all ByHeart products have been recalled, though some recalled cans and pouches are still being found on store shelves; the agency is working with states and retailers to remove them.
- Lab testing tied to the outbreak found C. botulinum contamination: California confirmed botulism bacteria in an opened can fed to a sick infant, and subsequent testing detected C. botulinum type A in 5 of 36 ByHeart samples; ByHeart warned all lots may be contaminated.
- The FDA is investigating 84 infant botulism cases since August; 36 of those involved infant formula and more than one-third of those formula-related cases used ByHeart products (ByHeart accounts for roughly 1% of U.S. formula sales).
- FDA inspections have been conducted at ByHeart production sites (powder made in Allerton, Iowa; cans/distribution in Portland, Oregon); inspection activity is ongoing and results have not been released.
- State and retail checks after the recall still found product on shelves: Minnesota removed recalled items at four sites after 119 retail checks; investigators in Oregon and Arizona also found recalled product a week after the nationwide recall; Walmart said it blocked sales, removed product and will refund customers (cans retailed around $42).
- Health officials and ByHeart instruct parents to immediately discontinue use and dispose of ByHeart formula; officials advise labeling any ByHeart product 'DO NOT USE' and keeping it for possible testing if symptoms develop, contacting a health care provider or public hotlines (California hotline: 833-398-2022).
- Health authorities originally identified specific recalled lot numbers (206VABP/251261P2 and 206VABP/251131P2, Use by 01 Dec 2026) and cautioned additional lot numbers could be added as the investigation continues.
📰 Sources (6)
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.