Archive · 10 Nov 2025
ByHeart Formula Recalled After Preliminary Tests Show Bacteria Linked to Botulism
A company called ByHeart that makes baby formula is recalling some of its powdered formula.
This happened because some babies got very sick with a condition called botulism.
Health detectives in California tested some of the formula and found a germ that can cause botulism.
This germ makes a poison that can make babies weak and unable to move or breathe well.
All the sick babies are under 5 months old and have been treated with medicine.
The company is taking back the formula to keep more babies safe.
Scientists are still doing more tests to be absolutely sure about the germ.
Botulism is rare, and this is the first time it's been linked to powdered baby formula.
Preliminary tests on ByHeart infant formula indicate the presence of bacteria that can produce the botulism toxin.
At least 13 infants, aged 2 weeks to 5 months, have been hospitalized with infant botulism across 10 states since mid-August.
ByHeart has recalled two lots of its Whole Nutrition Infant Formula with a best-by date of December 2026.
The FDA and CDC are investigating the outbreak, with California health officials conducting preliminary tests on the formula.
While ByHeart acknowledges the investigation, the company states more testing is needed to confirm the presence of the specific bacteria.
- Who
- ByHeart Inc., 13 infants, California health officials, FDA, CDC
- What
- ByHeart Inc. has recalled two lots of its Whole Nutrition Infant Formula after preliminary tests by California health officials indicated the presence of bacteria that produces the botulism toxin. At least 13 infants have been hospitalized with infant botulism since mid-August.
- When
- Since mid-August; recall and statements issued late Saturday/Sunday.
- Where
- Cases reported in 10 states across the United States.
- Why
- To address potential contamination linked to infant botulism following preliminary test results, though ByHeart states further testing is required for confirmation.
California Health Officials
ByHeart
Presence of Bacteria
California Health Officials
Preliminary tests suggest the presence of the type of bacteria that produces the botulism toxin.
ByHeart
More testing is needed to confirm whether the specific type of bacteria that causes botulism is present; many related bacteria are naturally occurring and harmless.
Recall Action
California Health Officials
Issued a statement urging consumers to stop using the product immediately.
ByHeart
Agreed to recall two lots of the powdered product as a proactive safety measure.
- Company
- ByHeart Inc.
- Product Recalled
- Whole Nutrition Infant Formula (two lots)
- Health Issue
- Infant botulism
- Reported Cases
- 13 infants sickened since mid-August
- Affected Age Group
- Infants aged 2 weeks to 5 months
- Affected States
- Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington
- Investigating Agencies
- FDA, CDC, California Department of Public Health
- Best-by Date
- December 2026
