A nationwide alert has been issued following a serious infant formula recall botulism incident involving ByHeart Whole Nutrition Infant Formula. As of November 12, 2025, federal health authorities have confirmed multiple cases of infant botulism linked to this product, with at least fifteen infants hospitalized across twelve U.S. states.
Overview of the Recall
The recall began after health officials detected possible contamination with Clostridium botulinum—a bacterium that produces a dangerous neurotoxin. Initially, two specific production lots of ByHeart Whole Nutrition Infant Formula were recalled. However, as testing expanded and additional illnesses were reported, the recall grew to include all unexpired lots and all package sizes of the formula.
ByHeart, a small U.S.-based manufacturer, sells its products both online and through retail partners nationwide. Although the brand represents less than one percent of the infant formula market, the potential contamination has drawn national concern.
Fortunately, no deaths have been reported. Still, health experts emphasize that the condition can be severe and that the recall is being treated as an urgent public health matter.
What Is Infant Botulism?
Infant botulism occurs when babies ingest spores of the bacterium Clostridium botulinum, which then grow inside the intestines and release toxins that interfere with nerve function.
Common early symptoms include:
- Constipation
- Weak cry
- Poor feeding or sucking
- Loss of facial expression
- Trouble swallowing
- Reduced head control
If untreated, the condition can progress to muscle weakness and breathing difficulties, making it a medical emergency.
Because infants’ digestive systems are not yet fully developed, they are more vulnerable to this kind of bacterial growth and toxin production.
Timeline of Events
- August 2025: First suspected cases of infant botulism are reported in several states.
- September–October 2025: Multiple hospitals begin identifying links between the affected infants and the same powdered formula brand.
- November 10, 2025: Federal officials confirm that samples of ByHeart Whole Nutrition Infant Formula tested positive for contamination.
- November 11, 2025: The company issues a voluntary nationwide recall covering all unexpired formula products.
- November 12, 2025: Ongoing testing and surveillance continue across the U.S.
States Reporting Cases
As of the latest update, confirmed or suspected cases of infant botulism linked to this recall have been identified in twelve U.S. states. The highest concentrations of reports have come from states with higher sales of ByHeart products, particularly in coastal and urban regions.
While the full list of affected states has not been released publicly, health departments across the country are urging pediatricians to remain alert for new cases.
Actions for Parents and Caregivers
Parents and caregivers are urged to take the following steps immediately:
- Stop Using ByHeart Formula:
If you have any unexpired ByHeart Whole Nutrition Infant Formula, stop feeding it to your baby immediately. - Check Lot Codes and Packaging:
Even if your lot number is not listed among the earliest recalled batches, the recall now covers all unexpired products. - Dispose of the Product Safely:
Seal the container, discard it in a closed trash bin, and clean any surface or bottle that came into contact with the formula using hot, soapy water. - Watch for Symptoms:
Monitor your baby for the warning signs of infant botulism. Seek medical attention right away if any symptoms appear. - Contact Your Pediatrician:
If your infant consumed the recalled formula but is not showing symptoms, contact your healthcare provider for guidance.
How the FDA and Health Officials Are Responding
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state health departments are conducting a joint investigation. The goal is to trace the contamination to its source—whether from raw materials, manufacturing conditions, or post-production handling.
Retailers nationwide have been instructed to remove ByHeart formula from store shelves and online listings. Inspections are underway at the company’s production facilities to ensure compliance with federal safety standards.
The FDA has also recommended that healthcare professionals report any suspected cases of infant botulism linked to formula consumption.
Why the Recall Is Alarming
Although ByHeart holds a very small share of the formula market, the outbreak has drawn attention due to its unusual nature. Infant botulism is rare in the United States, with only a few dozen cases typically reported each year—and it is almost never linked to commercial formula.
This marks one of the first confirmed cases in recent history where a U.S.-manufactured powdered formula was connected to a cluster of infant botulism cases.
Public health experts have emphasized that this incident highlights the ongoing challenges of maintaining safe production environments for infant nutrition products, especially in smaller manufacturing facilities.
What This Means for Parents Nationwide
For U.S. parents, this recall is a reminder of how critical it is to stay informed about food safety alerts and product recalls. Even if you don’t use ByHeart products, it’s a good idea to:
- Regularly check the FDA’s recall page for infant and baby products.
- Keep packaging and receipts for all baby formula purchases.
- Report any suspected illness promptly to your healthcare provider.
Despite the seriousness of the situation, major formula brands remain unaffected, and no nationwide shortage is expected as of now. Other major manufacturers continue to supply stores with safe alternatives.
Looking Ahead
The ongoing investigation aims to determine exactly how contamination occurred and whether any corrective actions are needed across the broader industry. ByHeart has stated that it is cooperating fully with regulators and conducting internal reviews to strengthen safety testing and manufacturing oversight.
Officials expect additional test results and inspection findings in the coming weeks. In the meantime, all unexpired lots of ByHeart Whole Nutrition Infant Formula remain under recall, and parents are advised not to use any remaining stock.
Bottom Line
The infant formula recall botulism case serves as a crucial reminder that even trusted baby products can pose risks if contamination occurs. Parents should immediately stop using the recalled formula, monitor infants closely for any symptoms, and consult a doctor at the first sign of illness.
Stay alert, check your formula packaging, and share this information with other caregivers to help keep infants safe.