FDA Criticizes Retailers for Failing to Withdraw Recalled ByHeart Infant Formula

The FDA has issued a warning regarding the continued sale of ByHeart’s Whole Pasture-Raised Goat Milk Infant Formula, which was recalled due to potential contamination with Clostridium botulinum. Despite the recall notice issued in late 2024, major retailers such as Target and Walmart failed to remove the product fr om shelves, resulting in over 1,100 units being sold.

Botulism is a rare but potentially fatal paralytic illness, and the presence of Clostridium botulinum in infant formula is particularly concerning. The recall process was initiated by ByHeart; however, the execution at the retail level was inadequate. The FDA’s investigation revealed that some retailers either lacked the necessary automated systems to block sales at the register or did not effectively implement manual checks.

This incident highlights significant weaknesses in the retail supply chain, particularly the so-called “last mile” wh ere products are transferred from warehouses to store shelves. The FDA has taken the unusual step of naming the retailers involved, aiming to pressure the industry into adopting more stringent compliance measures. The case underscores the importance of reliable inventory tracking systems to prevent similar public health risks in the future.

For ByHeart, the situation presents both legal and reputational challenges. The company had positioned itself as a premium alternative in the competitive infant formula market. Although no cases of illness have been confirmed thus far, the potential for severe symptoms such as blurred vision or respiratory failure necessitates a complete withdrawal of the affected batches.

As the dairy industry moves forward, the ByHeart recall is expected to prompt stricter regulations around infant formula distribution. Producers are urged to ensure comprehensive safety measures are in place, extending beyond the manufacturing stage to include retail partnerships and auditing processes.