ByHeart Recalls All Baby Formula Products Nationwide After Botulism Reports
By Rachel Dapeer · Published November 11, 2025 · Updated November 14, 2025
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- ByHeart has recalled every lot of its powdered infant formula nationwide after reports of botulism‐like illness.
- Fifteen infants in 12 states were hospitalized; no fatalities have been confirmed.
- FDA testing linked the illnesses to bacteria detected in an opened can connected to one case.
Key Facts
- Products included: ByHeart Whole Nutrition Infant Formula and ByHeart Anywhere Pack powdered formula.
- All cans and pouches are affected, regardless of production date or lot code.
- Parents and caregivers are advised to discontinue use and discard the product.
Background
The U.S. Food and Drug Administration (FDA) opened an investigation after several cases of infant botulism were reported. An opened can associated with one hospitalized infant tested positive for bacteria capable of producing botulinum toxin. Although unopened cans tested negative, ByHeart expanded the recall nationwide “out of an abundance of caution.”
Reported Illnesses
- Total affected infants: 15
- States involved: 12 (specific states not disclosed in the company announcement)
- Hospitalizations: 15
- Deaths: None reported as of the latest update
Symptoms to Watch For
Pediatricians recommend monitoring infants who consumed the recalled formula for potential signs of botulism:
- Constipation
- Weak muscle tone or poor head control
- Drooping eyelids
- Feeding difficulties
- Breathing problems
Immediate medical evaluation is advised if any of these symptoms appear.
What’s Next
- FDA inspections and testing of ByHeart production facilities are ongoing.
- The company reports it is cooperating with federal regulators to identify and eliminate the contamination source.
- No timeline has been provided for resuming production or sales.
Official Sources
Further information, including detailed recall notices and refund instructions, can be found on ByHeart’s official website and through FDA recall announcements.