A major infant formula recall botulism warning has captured national attention after health officials linked several cases of infant botulism to ByHeart Whole Nutrition Infant Formula. The recall, now expanded across the United States, has parents on high alert. As of November 12, 2025, at least fifteen infants across twelve states have been hospitalized, and federal health authorities continue to investigate the source of contamination.
This development has raised serious concerns about infant food safety and manufacturing oversight. Below is everything U.S. parents and caregivers need to know — explained clearly, factually, and without unnecessary panic.
Table of Contents
Overview of the Recall
ByHeart, a New York–based infant nutrition company, issued a nationwide recall after federal testing linked its powdered formula to possible contamination by Clostridium botulinum, a bacterium that produces a deadly neurotoxin.
Initially, only two production lots were affected. However, after further testing and new illness reports, the company voluntarily expanded the recall to all unexpired lots of ByHeart Whole Nutrition Infant Formula. This includes all container sizes and single-serving packets sold both online and in stores.
Though no deaths have been reported, the recall remains one of the most serious in recent years due to the potential severity of botulism in infants.
What Is Infant Botulism?
Infant botulism occurs when spores of Clostridium botulinum enter the body and produce toxins inside an infant’s intestines. This condition affects the nervous system, leading to muscle weakness, breathing difficulties, and, if untreated, paralysis.
Unlike adults, infants under 12 months lack the mature gut bacteria that can suppress these spores, making them more vulnerable. The illness develops gradually, sometimes taking several days or even weeks after exposure to show symptoms.
Common early signs include:
- Constipation
- Weak cry or decreased facial expression
- Trouble sucking or swallowing
- Poor feeding
- Loss of head control
- Generalized muscle weakness
If left untreated, the condition can progress rapidly, resulting in breathing problems that require hospitalization. Immediate medical care is essential if any symptoms are noticed.
How the Recall Unfolded
August – October 2025: Early Reports
Doctors began seeing isolated cases of infant botulism in multiple states. As more hospitals reported similar illnesses, investigators noticed that the affected babies had one thing in common: all had consumed ByHeart Whole Nutrition Infant Formula.
November 10, 2025: Laboratory Confirmation
Samples of used formula cans from several homes tested positive for C. botulinum spores. Although unopened cans initially tested negative, the findings prompted immediate federal action due to the high risk to infants.
November 11, 2025: Nationwide Recall
ByHeart issued a voluntary recall of all unexpired batches of its infant formula, affecting thousands of products distributed nationwide through both major retailers and online platforms.
Ongoing Investigation
Federal and state investigators are now tracing the contamination source, reviewing factory conditions, ingredient suppliers, and packaging procedures to determine how the bacteria entered the product.
States Affected and Scope of Recall
Confirmed or suspected infant botulism cases linked to the formula have been reported in twelve states. Health officials continue to test products and interview families to identify additional cases.
The recall applies to every unexpired container of ByHeart Whole Nutrition Infant Formula, including both the standard tubs and the portable “Anywhere Pack” pouches.
Retailers were instructed to immediately remove the affected products from shelves, and online listings were taken down within hours of the recall notice.
Actions Parents Should Take Immediately
If you purchased or used ByHeart Whole Nutrition Infant Formula, follow these steps:
- Stop Using the Product
Discontinue use immediately, even if your infant shows no symptoms. The recall applies to all unexpired lots. - Check Your Packaging
Record or photograph the product’s lot number and expiration date. Keeping this information may assist health authorities in ongoing investigations. - Dispose of the Formula Safely
Seal and discard the product in a secure trash bin. Clean any baby bottles, scoops, or containers that came into contact with the formula using hot, soapy water or a dishwasher. - Watch for Symptoms
Monitor your baby for any of the signs of infant botulism — especially difficulty feeding, constipation, weak cry, or drooping eyelids. Seek immediate medical help if any appear. - Consult Your Pediatrician
If your baby consumed the formula, contact your pediatrician. Even if your child appears well, a healthcare provider may want to monitor for early symptoms. - Do Not Share or Donate the Formula
Do not give the product to anyone else. Proper disposal helps prevent further risk to other infants.
What Authorities Are Doing
Health agencies have launched a multi-level investigation involving the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and several state health departments.
Manufacturing Inspections
Inspectors are reviewing ByHeart’s production sites, testing equipment, and storage conditions to determine the contamination source. They are also analyzing samples of raw materials used in production.
Retail and Consumer Safety
Stores nationwide were ordered to remove ByHeart products from their shelves immediately. Online platforms complied with removal requests within 24 hours.
Medical Alerts
Hospitals and pediatricians received nationwide advisories to be on alert for symptoms of infant botulism in babies who may have consumed the recalled formula.
Understanding Why This Recall Matters
The incident has shocked many parents because ByHeart is known for marketing itself as a high-quality, small-batch formula brand. Despite its small market share—estimated at under 1% of total U.S. formula sales—it has appeared in a disproportionately high number of recent botulism-related reports.
Infant botulism cases in the United States are rare, with fewer than 100 reported annually. It is even rarer for commercial infant formula to be involved, which makes this recall one of the most significant safety alerts of its kind in recent years.
The event underscores the importance of strict manufacturing oversight, sterilization, and quality control across the entire formula industry, including smaller boutique brands.
What Parents Should Expect Next
As the investigation continues, health officials are expected to release additional test results from unopened cans and production-line samples. Authorities are also monitoring for new reports of illness linked to ByHeart formula.
Parents can expect:
- Continued updates from federal health agencies.
- Ongoing testing of factory environments and raw materials.
- New safety requirements for powdered infant formula manufacturing if lapses are confirmed.
- Company-led improvements to testing, packaging, and sanitation procedures.
Despite the recall, no nationwide infant formula shortage is expected. ByHeart’s market share is small, and other major formula manufacturers are continuing to supply stores without disruption.
How to Keep Your Baby Safe Going Forward
Here are a few important reminders to protect your infant from contamination risks:
- Always check product recall alerts before opening new baby formula containers.
- Keep your baby’s formula sealed tightly and stored in a cool, dry place.
- Never use formula past its expiration date.
- Wash your hands thoroughly before preparing formula.
- Sterilize bottles, nipples, and mixing utensils regularly.
- If you notice an unusual smell, texture, or clumping in any formula, do not use it.
Parents should also stay informed through official health channels for any future updates or expansions to the recall.
Potential Industry Impact
The infant formula recall botulism case is already prompting calls for stronger oversight. Lawmakers and consumer-safety advocates are pushing for more frequent inspections, mandatory contamination testing, and transparency in production reports.
This incident could also reshape how smaller formula manufacturers are regulated. Companies that operate on a limited production scale may face new rules requiring additional safety checks before shipping products nationwide.
Ultimately, this recall has reignited conversations about trust and accountability in infant nutrition — a topic that remains sensitive after past formula shortages and contamination scares.
The Bottom Line
The infant formula recall botulism event highlights the importance of vigilance, transparency, and proactive safety in the U.S. baby food industry. For parents, the most important action right now is simple: check your formula, stop using recalled products, and seek medical advice immediately if any symptoms appear.
While investigations continue, parents can take comfort in knowing that public health authorities are moving swiftly and that the number of cases remains limited. However, early awareness and quick action can make a critical difference in protecting infant health.
Stay aware, keep an eye on your baby’s formula, and share this information with other parents and caregivers to help keep every child safe. We invite you to share your thoughts, experiences, or questions below — your awareness could help another family stay informed.