An outbreak of infant botulism associated with baby formula has now affected **51 infants** across **19 states**, according to federal health officials. The **Food and Drug Administration (FDA)** and the **Centers for Disease Control and Prevention (CDC)** reported this development on **December 11, 2023**. The rise in cases follows a review of earlier reports dating back to late 2023 involving infants who consumed formula from **ByHeart Whole Nutrition**.
The FDA stated that it “cannot rule out the possibility that contamination might have affected all ByHeart formula products.” This concern has prompted the CDC to expand its case definition. Now, any infant diagnosed with botulism and who was exposed to ByHeart formula since its release in **March 2022** will be included in the investigation.
The CDC emphasized the seriousness of botulism, a rare but potentially life-threatening illness caused by a toxin produced by the bacterium *Clostridium botulinum*. Symptoms can manifest as weakness, poor feeding, and constipation in infants. In severe cases, the illness may lead to respiratory failure.
Officials have urged parents and caregivers to remain vigilant and to seek immediate medical attention if an infant exhibits any signs of botulism. The FDA has indicated that it is working closely with ByHeart to address the situation, including assessing manufacturing practices to ensure product safety.
As the situation develops, the CDC and FDA continue to monitor reported cases closely. Public health officials are advising that any infants who might have ingested ByHeart formula should be evaluated by a healthcare professional, even if they are not currently showing symptoms.
This outbreak highlights the importance of stringent food safety measures, particularly concerning products intended for vulnerable populations such as infants. Given the potential risks associated with baby formula, parents are encouraged to stay informed and prioritize safety when selecting infant nutrition products.
The investigation is ongoing, and further updates will be provided as more information becomes available.
