ByHeart submits its **root cause investigation and action plan** to the FDA following facility inspections. The company addresses the **November 2025 infant botulism outbreak** linked to its infant formula. ByHeart now awaits regulatory review before resuming production.
The FDA concludes a botulism outbreak linked to ByHeart infant formula, involving 48 confirmed and probable cases. Whole-genome sequencing (WGS) evidence was used extensively in the investigation, though the root cause remains unidentified. The agency also introduces new resources, 'Operation Stork Speed,' to support families affected by infant formula shortages.
The FDA recalls ByHeart infant formula after an outbreak of infant botulism linked to contaminated batches. Babies in the US develop the rare but serious illness following consumption of the affected product. Regulatory agencies highlight systemic food safety gaps amid the investigation.
Investigators in at least three states locate ByHeart infant formula on shelves a week after its voluntary recall due to infant botulism risks. The recalled products remain available despite the company’s withdrawal announcement. Health authorities continue monitoring cases linked to the formula.
