Lead: Federal health officials have linked ByHeart Whole Nutrition powdered infant formula to a multi-state cluster of infant botulism, prompting a voluntary recall of two lots with Dec. 1 “use by” dates. The U.S. Food and Drug Administration (FDA) says the outbreak spans 10 states and includes 13 hospitalizations since August; no deaths have been reported. Parents and caregivers are being urged to check packaging lot numbers and dispose of affected containers while investigators work to identify any contamination source. Retailers are removing potentially impacted product from shelves as laboratory testing continues.
Key Takeaways
- The FDA reported 13 hospitalizations linked to children who consumed ByHeart Whole Nutrition Infant Formula; those illnesses have been tracked since August.
- At least 83 reports of suspected infant botulism were estimated nationwide, according to company briefings to regulators; the agency is investigating which cases are linked to ByHeart.
- The recall covers two powdered formula lot numbers: 206VABP/251261P2 and 206VABP/251131P2, both carrying a Dec. 1 “use by” date.
- Illnesses have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
- The FDA advised caregivers to record identifying data printed on the bottom of containers and discard any product from the recalled lots immediately.
- ByHeart manufactures formula in facilities located in Iowa, Pennsylvania and Oregon and distributes through nearly 12,000 retail outlets; the company accounts for under 1% of U.S. baby-formula sales, per the FDA.
- Federal and state laboratories are testing leftover product; results are expected in the coming weeks as officials try to determine a contamination point and whether other products are affected.
- Infant botulism is treatable with BabyBIG (botulism immune globulin), an FDA-approved therapy; early recognition and hospitalization can be lifesaving.
Background
Infant botulism is a rare but serious illness caused by ingestion and intestinal production of botulinum neurotoxin, most often stemming from environmental spores that germinate in an infant’s gut. Symptoms typically begin with constipation and poor feeding and can progress to weak cry, loss of head control, trouble swallowing and descending paralysis. The Centers for Disease Control and Prevention (CDC) has long advised clinicians and parents to watch for those signs, since prompt diagnosis and treatment improve outcomes.
Manufacturers of infant formula operate in a tightly regulated sector with multiple safety, testing and traceability requirements enforced by state and federal agencies. Recalls of baby food products are uncommon and tend to trigger heightened public concern because of infants’ vulnerability. ByHeart markets an organic, grass-fed whole-milk formula positioned as closer in composition to breast milk; the company sells through retail partners nationwide but remains a small share of the overall market.
Main Event
The FDA announced a recall covering two lots of ByHeart Whole Nutrition Infant Formula after receiving reports linking the product to infant botulism cases spanning 10 states. The agency said the cluster includes 13 hospitalizations reported since August among children who consumed the formula. Investigators flagged two lot numbers printed on the bottom of recalled containers: 206VABP/251261P2 and 206VABP/251131P2, both carrying Dec. 1 “use by” dates.
ByHeart told regulators it was informed Friday that the FDA had tracked an estimated 83 reports of infant botulism since August and that 13 of those reports involved babies who had consumed the company’s formula. Company and government laboratory tests reported to date have not detected botulinum toxin in tested samples of the product, according to public statements, and the FDA said it had not yet identified a definitive link between the formula and all reported cases.
The agency has asked caregivers to record the lot and identifying information printed on the bottom of any ByHeart containers they have and to dispose of product from the two recalled lots. Officials are working with retailers to remove potentially affected packages from store shelves and distribution channels. State public-health laboratories are conducting testing on leftover formula, and the FDA said further results are expected in the coming weeks.
Analysis & Implications
Short-term public-health priorities are clear: identify whether the recalled lots contain botulinum toxin or spores, and determine whether a common contamination point exists in production, packaging or distribution. If testing shows contamination localized to the two recalled lots, health officials can narrow their response to those batches. If testing is inconclusive or identifies a broader contamination, regulators may widen the recall and heighten scrutiny across suppliers.
From a regulatory and industry perspective, even an isolated contamination event in a small-brand formula can have outsized consequences. Infant-formula supply chains are interlinked with ingredient sourcing, contract manufacturing and third-party packaging—any vulnerability uncovered by investigators could prompt broader inspections and procedural changes across producers. Retail recalls and negative publicity also risk eroding consumer confidence, which can shift demand to other brands and complicate supply dynamics for families who rely on specialty formulas.
Clinically, the cluster underlines the importance of rapid recognition and treatment. Infant botulism is rare, but the observed 13 hospitalizations since August show how severe cases can be even when numbers are small. The availability and timely administration of BabyBIG are crucial; public-health messaging should emphasize symptom awareness and prompt medical evaluation rather than causing panic among caregivers who do not have the recalled lots.
Comparison & Data
| Item | Reported figure |
|---|---|
| Hospitalizations linked to affected infants | 13 (since August) |
| Estimated national reports of infant botulism (company brief to regulators) | ~83 |
| Recalled lot numbers | 206VABP/251261P2, 206VABP/251131P2 (Dec. 1 use-by) |
| States reporting cases | AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA |
| ByHeart U.S. market share (approx.) | Less than 1% |
The table summarizes the known numerical signals from agency and company statements. Numbers are limited: while the company reported an estimated 83 nationwide reports to regulators, only 13 hospitalized infants are confirmed to have consumed the product. Public-health agencies are prioritizing laboratory confirmation to reconcile these figures and to establish whether additional products or lots are implicated.
Reactions & Quotes
“ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
ByHeart (company statement)
ByHeart framed the recall as a precaution while its own tests and government testing proceed. The company reiterated that no historic precedent links infant formula as a common source of infant botulism.
“Caregivers who have fed ByHeart to children recently should keep a close eye on them as a precaution, as botulism can take weeks to develop.”
U.S. Food and Drug Administration (public advisory)
The FDA stressed monitoring of exposed infants and signaled that laboratory results will determine next steps. State health departments, notably California’s, have separately reported increases in infant botulism cases among infants who consumed ByHeart formula since August.
Unconfirmed
- The FDA has not yet identified a definitive causal link between the formula and all reported infant-botulism cases; laboratory testing is ongoing.
- Company statements cited an estimated 83 nationwide reports to regulators, but the relationship between those reports and confirmed cases tied specifically to ByHeart product remains under investigation.
- It is not yet known whether contamination, if present, occurred at a production facility, during packaging, or in downstream handling—investigators are still determining the point of contamination.
Bottom Line
The recall is a precautionary response to a cluster of severe infant illnesses; 13 hospitalized cases and approximately 83 reported incidents nationally have prompted regulators to act while laboratory testing is completed. At present, no deaths have been reported and both company and government tests have not confirmed toxin in tested samples, but that uncertainty is driving the recall and removal of product from shelves.
Caregivers should immediately check ByHeart containers for the two affected lot numbers and discard any matching product, while monitoring infants for early signs of botulism and seeking prompt medical care if symptoms appear. In the coming weeks, test results and traceback investigations will determine whether the issue is isolated or indicative of a broader manufacturing or supply-chain problem, and those findings will shape regulatory and industry responses.
Sources
- NBC News — news report summarizing FDA and company statements (media).
- Centers for Disease Control and Prevention (CDC) — clinical overview and treatment guidance for infant botulism (official public-health guidance).
- U.S. Food and Drug Administration (FDA) — federal regulator coordinating testing and recalls (official agency).
- ByHeart — company website and published statements regarding the recall and product information (company/official).