At a Glance
- ByHeart formula found to contain botulism-causing bacteria.
- 51 babies in 19 states sickened since December 2023.
- FDA testing traced contamination to powdered whole milk used in the formula.
- Why it matters: Parents may unknowingly feed infants a contaminated product.
ByHeart, a New York-based infant-formula company, has been thrust into a national health crisis after the U.S. Food and Drug Administration (FDA) linked its product to an outbreak of botulism that has sickened 51 babies across 19 states since December 2023.
FDA Finds Contamination in Powdered Milk
In a series of tests, the FDA discovered the toxin-producing bacteria Clostridium botulinum in two samples that were directly tied to ByHeart formula. The agency reported that an unopened can of the formula matched a sample from a sick baby, and that the same bacterial strain was found in organic whole-milk powder used to make the formula.
The agency’s findings were not definitive but raised serious concerns about the supply chain:
- Bacteria in an unopened can matched a baby’s sample.
- The same strain was detected in powdered milk collected by ByHeart.
- A separate sample of whole-milk powder supplied to the company also matched the germ.
The FDA stated the investigation is ongoing to determine the exact source of the contamination.
ByHeart’s Response
A ByHeart official said the findings help clarify a “watershed moment” for the company. ByHeart‘s chief scientific and medical officer, Dr. Devon Kuehn, explained:
> “We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula.”
ByHeart initially recalled two lots of formula in November, then expanded the recall to all products a few days later. Federal health officials said they could not rule out contamination of all products made since the company launched in March 2022.
Legal and Industry Implications
Food-safety advocates and lawyers are calling for stricter testing of raw materials. Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, said:
> “FDA has not announced a plan to do testing, and that’s what we really want to see them do.”
Bill Marler, a Seattle food-safety lawyer representing more than 30 families of ill babies, added:
> “Just because they are able to point the finger at dried powder as the ingredient that may have been contaminated, it doesn’t take any of the legal or moral responsibility away from ByHeart.”
Market Impact
ByHeart accounted for about 1% of the U.S. infant-formula market, selling roughly 200,000 cans per month. The product, marketed as a close alternative to human breast milk and priced at about $42 per can, was chosen by parents seeking organic, grass-fed whole-milk benefits.
The outbreak’s unprecedented scale has shaken consumer confidence in infant formula. While the FDA says there is no indication of a broader problem in the supply chain, the incident has prompted calls for mandatory testing of both raw ingredients and finished products.
Timeline of Events
| Date | Event |
|---|---|
| December 2023 | First cases of botulism linked to ByHeart identified by California program. |
| Mid-December 2023 | CDC reports no new cases since mid-December. |
| November 2023 | ByHeart recalls two lots; later expands recall to all products. |
| Late November 2023 | FDA tests find C. botulinum in six of 36 formula samples. |
| December 2023 | FDA announces investigation into powdered milk source. |
What Botulism Means for Babies
Botulism is a rare but severe illness that attacks the nerves. Infants are especially vulnerable, and symptoms can include muscle weakness, poor feeding, and respiratory failure. Early detection and treatment are critical, but the best prevention is avoiding contaminated products.
Looking Ahead
The FDA’s investigation is still ongoing, and the agency has not named the powdered-milk supplier. ByHeart’s legal team continues to defend the company’s responsibility, while consumer advocacy groups push for stricter oversight. Parents are urged to monitor recalls and consult healthcare providers if they suspect exposure.
Key Takeaway: The ByHeart botulism outbreak underscores the importance of rigorous testing and transparency in the infant-formula industry.
