Federal and state health authorities announced on November 8, 2025, that they are investigating 13 cases of infant botulism across 10 U.S. states tied to a voluntary recall of ByHeart Whole Nutrition Infant Formula. The Food and Drug Administration said ByHeart agreed to recall two production lots after all 13 infants were hospitalized but no deaths were reported. The cases were identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. Officials are probing how contamination occurred and whether additional products or lots are affected.
Key takeaways
- Thirteen confirmed infant botulism hospitalizations across 10 states were reported as of November 8, 2025.
- ByHeart voluntarily recalled two lots of Whole Nutrition Infant Formula: 206VABP/251261P2 and 206VABP/251131P2.
- No deaths have been reported in the identified cases; all 13 infants required hospital care.
- The affected product represented about 1% of national formula sales, according to the U.S. Centers for Disease Control and Prevention.
- The CDC advises caregivers to record lot numbers before discarding or returning recalled products and to clean items with a dishwasher or hot, soapy water.
- Symptoms can take days to weeks to appear and include constipation, poor feeding, drooping eyelids and respiratory difficulty; seek immediate medical care for those signs.
Background
Infant botulism is a rare but serious illness caused when Clostridium botulinum spores germinate and produce toxin in a baby s large intestine. Historically, infant botulism cases in the United States have been associated with environmental exposures such as honey or soil, and occasional links to contaminated products prompt public health investigations and recalls.
Commercial infant formula undergoes multiple safety checks, but complex supply chains and production processes can create vulnerability if contamination occurs at a single point. Federal regulators, state health departments and manufacturers typically mobilize together when clusters are identified to limit spread and to trace the source.
Main event
On November 8, 2025, the FDA said ByHeart Inc. agreed to a voluntary recall of two specific lots of its Whole Nutrition Infant Formula after state and federal investigators linked the lots to 13 hospitalizations for infant botulism. The company s recall notice covered lots 206VABP/251261P2 and 206VABP/251131P2 and urged consumers to stop using affected cans immediately.
Public health investigators across Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington identified infants who had consumed formula from those lots and subsequently developed symptoms consistent with infant botulism. Each case required hospitalization for evaluation and treatment; health authorities reported no fatalities related to these events.
The CDC has instructed caregivers to preserve lot numbers if possible when disposing of or returning recalled product and to thoroughly clean any feeding items and surfaces with a dishwasher or hot, soapy water. Health officials emphasized early clinical evaluation for infants who develop poor feeding, loss of head control, difficulty swallowing or diminished facial expression after consuming the recalled product.
Analysis & implications
A recall tied to infant botulism raises immediate concerns about manufacturing controls, environmental contamination at a production site, or raw ingredient integrity. The FDA s investigation aims to identify a contamination point and to determine whether other lots or product lines might be affected. If the contamination source is linked to a supplier or facility, regulatory actions and broader recalls could follow.
For families and clinicians, the primary consequence is heightened vigilance. Symptoms of infant botulism can emerge over several days to weeks, and early recognition is critical because antitoxin treatment and supportive respiratory care can dramatically change outcomes. Public messaging from health agencies seeks to balance urgency with reassurance that the identified cases are being managed.
Economically, the recall affects a product that the CDC estimates accounts for about 1 percent of national formula sales, a relatively small share of the market but one that can still cause disruption for impacted families. If investigations find broader contamination, supply-chain effects could widen, prompting stock shifts, retailer returns and potential regulatory penalties.
Comparison & data
| Metric | Value |
|---|---|
| Total confirmed cases | 13 |
| States affected | 10 (AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA) |
| Recalled lots | 206VABP/251261P2, 206VABP/251131P2 |
| Reported deaths | 0 |
| Estimated market share of product | ~1% of national formula sales (CDC) |
The table above summarizes confirmed figures released by federal and state health agencies as of November 8, 2025. Detailed counts by state were not released publicly; investigators are still compiling case timelines, exposure histories and laboratory results to map the cluster precisely.
Reactions & quotes
Company response and public health messaging have been prominent since the recall notice.
We place infant safety first and have initiated a voluntary recall of the identified lots as a precaution while investigators complete their review.
ByHeart Inc., company statement
Federal and state agencies emphasized investigation and care guidance.
CDC and state partners are working with clinicians and families to identify any additional cases and to provide immediate guidance on recognition and care.
U.S. Centers for Disease Control and Prevention
The FDA has opened an inquiry into production and distribution records to determine how contamination could have occurred and whether other products are at risk.
U.S. Food and Drug Administration
Unconfirmed
- Exact distribution of the 13 cases by state has not been publicly released in full; specific county-level details remain under investigation.
- The definitive contamination source and whether it occurred during manufacturing, packaging or via an ingredient supplier have not been confirmed.
- It is not yet determined whether any other ByHeart lots or product lines beyond the two identified lots are affected.
Bottom line
The voluntary recall of two ByHeart formula lots follows 13 infant hospitalizations for botulism across 10 states and has prompted federal and state investigations. No deaths have been reported, but the cluster highlights how even a small number of contaminated units can result in serious illness given infants vulnerability.
Caregivers who purchased the specified lots should record lot numbers, stop using the product, follow CDC cleaning guidance and seek immediate medical evaluation if an infant shows signs such as poor feeding, loss of head control, drooping eyelids or respiratory difficulty. Regulators will need to identify the contamination pathway to determine whether broader recalls or corrective actions are required; families and clinicians should monitor official updates from the FDA and CDC.
Sources
- CBS News (news report)
- U.S. Centers for Disease Control and Prevention (federal public health guidance)
- U.S. Food and Drug Administration (federal regulator updates)