The US Food and Drug Administration (FDA) has launched a nationwide recall of ByHeart Whole Nutrition Infant Formula after confirming it is linked to a multistate outbreak of infant botulism.
The recall applies to all lots of the formula, including both standard cans and single‑serve “anywhere pack” sticks, and covers products sold online and at major retailers.
To date, 39 infants across18 US states have been hospitalised with suspected or confirmed botulism after consuming ByHeart formula.
Symptoms of infant botulism can take several weeks to develop and include constipation, poor feeding, hypotonia, difficulty swallowing, weak cry, and in severe cases, respiratory paralysis.
No deaths have been reported.
Contamination testing and findings
Comprehensive testing was conducted on unopened product samples by ByHeart, the FDA, the Centers for Disease Control and Prevention (CDC), and state public-health laboratories.
Five of 36 samples across three lots tested positive for Clostridium botulinum Type A, the bacterium responsible for botulism.
Infant formula manufacturing typically occurs under controlled environments with cleanroom standards to minimise microbial contamination.
The detection of C. botulinum suggests potential gaps in environmental monitoring, aseptic processing or sanitation protocols.
The FDA is conducting thorough inspections of ByHeart’s production facilities, including assessment of cleanroom classification, airflow integrity, equipment sterilisation, and hygiene practices.
Next steps
Caregivers are advised not to use any ByHeart formula, regardless of lot number or purchase date.
Retailers and local authorities have been instructed to remove all affected products from sale immediately, although some items are still continuing to appear on store shelves.
Unopened product from multiple lots remains under analysis as regulatory agencies work to determine the source and point of contamination.
The recall highlights the critical importance of robust microbial risk management, environmental monitoring and adherence to GMP standards in infant formula production.