Federal health officials report 31 infants hospitalized across 15 states for infant botulism after consuming ByHeart Whole Nutrition infant formula since August 2025. The outbreak has prompted a nationwide recall of all ByHeart products, yet inspectors continue to find the formula on store shelves in several areas.
Outbreak Details and Case Surge
Health agencies like the FDA and CDC have tracked this rare but serious illness in babies under one year old. The cases involve infants as young as two weeks and up to six months, with the latest reported on November 13, 2025. No deaths have occurred, but all affected babies needed hospital care and treatment with an antitoxin called BabyBIG.
Parents first notice symptoms weeks after exposure, which makes early detection tricky. The bacteria Clostridium botulinum produces toxins that paralyze muscles in young infants whose guts cannot fight them off. This outbreak stands out because ByHeart holds only about one percent of the formula market, yet it links to a disproportionate number of cases.
Experts point to production issues at ByHeart facilities in Iowa and Oregon as possible sources. Recent inspections revealed sanitation lapses, echoing problems from past formula crises like the 2022 Abbott recall that caused shortages nationwide.
Lab Tests Confirm Contamination
Independent lab results released this week show Clostridium botulinum in some ByHeart formula samples. The company shared these findings on its website, noting they informed the FDA right away. Tests focused on opened containers fed to sick infants, with one from California confirming the bacteria.
ByHeart stressed that unopened cans tested negative so far, but they expanded the recall to all batches out of caution. The firm apologized to families and set up a hotline for support. Critics say the initial response downplayed risks by citing broader botulism stats, delaying full action.
This confirmation builds on earlier state lab work. For instance, health departments in multiple areas cultured samples from affected households. The data points to post-production contamination, possibly during mixing or storage, though the exact cause remains under review.
Recalled Formula Lingers on Shelves
Despite the November 11 recall of all ByHeart infant formula, state officials report products still available in stores. Inspectors in Oregon, New York, Arizona, and Minnesota pulled tainted cans from shelves this week. The FDA urges retailers to check lot numbers and remove items immediately.
| State | Confirmed Cases | Recent Shelf Findings |
|---|---|---|
| California | 8 | Yes, opened cans tested positive |
| New York | 5 | Multiple stores with unremoved stock |
| Texas | 4 | No recent reports |
| Oregon | 3 | Pulled from local retailers |
| Illinois | 3 | Ongoing checks |
| Other states (10 total) | 8 | Varied, some alerts issued |
This table highlights key states based on case reports and enforcement actions. Parents should scan bottoms of cans for batch codes like 251261P2 or 251131P2, even if past the initial recall dates.
Delays in removal raise safety concerns, especially since symptoms can appear long after purchase. Retailers face fines for non compliance, but supply chains complicate quick cleanups.
Symptoms to Watch and Immediate Steps
Infant botulism starts subtly but progresses fast, demanding quick medical help. Common early signs include constipation and weak sucking during feeds.
- Constipation lasting more than a few days
- Droopy eyelids or flat facial expressions
- Trouble swallowing or floppy muscle tone
- Weak cry or loss of head control
- Breathing issues in severe cases
If a baby shows these after formula use, seek emergency care right away. Discard any ByHeart formula, even if unopened, and label leftovers for investigators if asked. Clean bottles and utensils with hot soapy water or a dishwasher to remove potential toxins.
Switch to other trusted brands like Similac or Enfamil, which faced their own recalls but now meet strict standards. Breastfeeding remains the safest option where possible, reducing reliance on powdered products prone to contamination.
Broader Impact and Ongoing Probe
This crisis revives fears from the 2022 formula shortage, when bacterial issues hospitalized four babies and idled a major plant. ByHeart’s small market share means no widespread shortages, but it spotlights regulatory gaps. The FDA lost inspectors in 2025 budget cuts, slowing oversight.
Lawsuits from affected families claim negligence in production and warnings. The company offers refunds for recent online buys and works with Amazon on returns. Health experts call for better testing protocols to prevent future outbreaks.
Investigators trace the bacteria’s path, from raw milk sourcing to packaging. Preliminary findings suggest environmental spores entered during manufacturing. Full results could take weeks, but agencies promise updates.
Parents and caregivers, stay alert and share this info with your network to protect more little ones. Comment below on your experiences or tips for safe feeding, and spread the word to help others.
