Infant Formula Recall 2025: ByHeart Formula Linked to 10-State Botulism Outbreak
A nationwide investigation is underway after several infants were hospitalized with botulism linked to a recalled batch of ByHeart Whole Nutrition Infant Formula.
The Centers for Disease Control and Prevention (CDC), along with the U.S. Food and Drug Administration (FDA) and public health officials from multiple states, are working together to trace the source of the contamination.
Outbreak Overview
Since August 2025, 13 infants have been hospitalized across 10 U.S. states after developing symptoms of infant botulism, a rare but serious illness caused by Clostridium botulinum spores.
Fortunately, no deaths have been reported so far.
The affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Details of the Recall
On November 8, 2025, ByHeart Inc., an organic baby formula manufacturer based in New York City, voluntarily recalled two lots of its powdered infant formula as a precautionary measure:
- Lot 206VABP/251261P2 – “Use by 01 Dec 2026”
- Lot 206VABP/251131P2 – “Use by 01 Dec 2026”
The formula was sold nationwide and online through major retailers.
While ByHeart products account for less than 1% of U.S. formula sales, the recall has prompted widespread concern among parents and caregivers.
What Parents Should Do
The FDA advises parents not to use the recalled formula. Anyone who purchased it should dispose of it safely or return it to the retailer. Before doing so, record the lot number found at the bottom of the container.
Parents are also urged to clean all bottles, utensils, and surfaces that may have come in contact with the product using hot, soapy water or a dishwasher.
Symptoms to Watch For
Infant botulism develops when bacterial spores grow in a baby’s intestines and release toxins. Early signs often include:
- Constipation
- Weak sucking or feeding
- Decreased facial movement
- Trouble swallowing
- Loss of head control
- Lethargy or floppiness
Symptoms can appear weeks after exposure, so parents should remain alert even if their baby currently seems healthy.
Response from ByHeart
In a public statement, ByHeart said it was acting “out of an abundance of caution” and emphasized that no confirmed presence of botulism has been found in its products to date.
The company stated that both federal and in-house tests have so far shown no contamination, but it is cooperating fully with investigators.
“ByHeart is taking proactive steps to eliminate any potential risk and ensure the highest level of safety for infants,” the company said.
Ongoing Investigation
Officials from the FDA, CDC, and several state health departments are continuing to test leftover samples of the formula and investigate where contamination might have occurred—whether in production, packaging, or post-distribution handling.
Health experts stress that infant botulism remains rare, but can be serious if untreated.
Treatment with BabyBIG®, a specialized antitoxin available through the Infant Botulism Treatment and Prevention Program, has proven highly effective when administered promptly.
Frequently Asked Questions (FAQ)
1. What should I do if I used the recalled ByHeart formula?
Stop using it immediately. Discard the product safely or return it to the store. Wash all feeding tools and surfaces it may have touched.
2. How do I know if my baby’s formula is affected?
Check the lot numbers printed on the bottom of the can: 206VABP/251261P2 or 206VABP/251131P2.
3. What are the symptoms of infant botulism?
Common symptoms include constipation, poor feeding, weak cry, loss of head control, and muscle weakness.
4. Is there a treatment for infant botulism?
Yes. The FDA recommends BabyBIG®, an antibody-based treatment that neutralizes the botulinum toxin.
5. Will this cause a national baby formula shortage?
No. The FDA has confirmed that ByHeart products represent only about 1% of U.S. infant formula sales.