Infant Formula Recall in the US Due to Botulism Contamination

The U.S. infant formula market is facing a significant recall as ByHeart Inc. voluntarily withdraws two lots of its Whole Nutrition Infant Formula due to an outbreak of infant botulism. The affected lot codes are 206VABP/251261P2 and 206VABP/251131P2, with a use-by date of December 1, 2026. This recall follows the hospitalization of 13 infants across 10 states since mid-August 2025, highlighting a critical lapse in contamination control.

Botulism, a serious illness caused by Clostridium botulinum spores, is rare in dairy products, but its detection in infant formula has sent shockwaves through the sector. The spores, found naturally in soil and dust, can survive pasteurization, necessitating strict sanitation in manufacturing environments. The FDA and CDC have recommended the recall due to a strong epidemiological link between the formula and the illnesses, despite ByHeart's claims that their tests have not confirmed contamination.

The recalled product comprises less than 1% of the U.S. infant formula market, which minimizes the risk of a national shortage. However, the incident has prompted an FDA investigation to identify the contamination source, increasing scrutiny on all suppliers and manufacturers involved in powdered infant nutrition.

This event underscores the importance of rigorous HACCP plans and preventive controls throughout the dairy supply chain. The industry must reassess its risk management strategies to protect infant health and maintain trust in dairy-based nutrition products.