US FDA Issues Warning Letters to Major Retailers Over Recalled Infant Formula

Continued Sale of Recalled Products

The US Food and Drug Administration (FDA) has taken decisive action against major retailers Walmart, Target, Kroger, and Albertsons by issuing warning letters for their continued sale of recalled infant formula products. The ByHeart Whole Nutrition Infant Formula was recalled in November 2025 due to its association with a botulism outbreak in infants.

Safety Concerns and Regulatory Action

The FDA's action comes after inspections revealed that these retailers continued to display the recalled products on store shelves despite receiving recall notices. Botulism in infants can occur when they ingest spores of Clostridium botulinum, which can develop in their immature digestive systems and produce dangerous toxins. Symptoms include constipation, feeding difficulties, loss of head control, and swallowing issues, potentially leading to serious breathing problems in severe cases.

Public Health Implications

The Centers for Disease Control and Prevention (CDC) reported that the outbreak had affected 51 infants across 19 states, with ages ranging from two weeks to nearly nine months. This regulatory action by the FDA underscores the importance of strict compliance with food safety regulations, particularly for products intended for vulnerable populations like infants.