IEH Laboratories & Consulting Group, a third-party laboratory hired by ByHeart Inc. to test its powdered infant formula has recovered Clostrodium botulinum from an unspecified number of samples.

IEH tested sealed cans of ByHeart’s powdered infant formula, thus confirming that the contamination came from the product and was not as a result of consumer mishandling of the powdered formula during preparation or storage.

In a letter addressed “To families everywhere,” and posted on the company’s website, ByHeart did not reveal how many samples tested positive, or whether the positive samples represented more than one production lot.

On November 19, 2025, the CDC posted an update on its investigation into the infant botulism outbreak linked to ByHeart infant formula, announcing that 31 confirmed and suspect cases have been identified so far.

Unlike the better known form of botulism that results from ingesting of a pre-formed toxin, infant botulism occurs when a baby ingest spores of Clostridium botulinum. The spores travel through the stomach, grow and produce there toxin in the infant’s intestine.

To date, the Marler Clark law firm has filed three separate complaints against ByHeart Inc. on behalf of families whose infants were hospitalized after being fed the company’s infant formula.

Typical initial symptoms of infant botulism can include: poor feeding, loss of head control, difficulty swallowing, and decreased facial expression. If untreated, infant botulism can be deadly.

ByHeart has pledged to work with the FDA to identify the root cause of the Clostridium botulinum contamination.

Consumers need to be aware that, even though ByHeart did not distribute its products internationally, their infant formula was available for sale online. Both Canada and Trinidad and Tobago have issued warnings to consumers in those countries to avoid feeding ByHeart powdered infant formula to their infants.

According to the FDA, customer information provided by Amazon shows that a limited quantity of recalled ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and Virgin Islands.

What caregivers need to know (per CDC)

• Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
  • If possible, take a picture or record the lot number and best by date.
  • If you have leftover ByHeart powdered formula, label it “DO NOT USE” and keep it stored in a safe place for at least a month.
  • If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
• Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.

• Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
  • Poor feeding
  • Loss of head control
  • Difficulty swallowing
  • Decreased facial expression
• Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.
• California Department of Public Health has a public hotline to support caregivers with concerns about this outbreak and infant botulism.
  • Available Monday to Sunday, 7 a.m. to 11 p.m. Pacific Standard Time
  • 1-833-398-2022

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.