FDA investigating infant botulism outbreak linked to recalled baby formula
The agency indicated that state and local public health officials are interviewing caregivers about infants' feeding during the month prior to their illness. All 13 (100%) reported feeding them ByHeart Whole Nutrition infant formula.
FDA building
Authorities are investigating an outbreak of infant botulism in the country. The Food and Drug Administration explained that as of Nov. 8, 2025, 13 suspected or confirmed cases of infant botulism have been reported in 10 states: Arizona, California (two), Illinois (two), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (two) and Washington.
Similarly, the agency indicated that state and local public health officials are interviewing caregivers about infant feeding during the month prior to illness. All 13 (100%) reported giving them ByHeart Whole Nutrition baby formula.
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"Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available but expected in the coming weeks," the FDA detailed in a statement.
In that regard, officials noted that this Saturday ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition infant formula (lots 206VABP/251261P2 and 206VABP/251131P2) that were reportedly consumed by sick infants.
What should consumers do?
If an infant develops symptoms related to infant botulism, caregivers should contact their physician immediately. To report an illness or adverse event, you can:
- Call an FDA consumer complaint coordinator if you want to speak directly to a person about your problem.
- Fill out the digital MedWatch voluntary form online.
- Complete the physical MedWatch voluntary form that you can mail to FDA.
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