The U.S. Food and Drug Administration has issued formal warning letters to four of the nation’s largest retail chains after investigators discovered they continued to stock and sell infant formula tied to a dangerous bacterial outbreak, putting vulnerable babies at serious risk.
The Contaminated Product & The Outbreak
The recalled product, ByHeart Whole Nutrition Infant Formula, has been directly linked to an outbreak of infant botulism that has sickened 51 infants across 19 states. Infant botulism is a life-threatening illness caused by ingesting spores of Clostridium botulinum bacteria. Symptoms include severe constipation, feeding difficulties, loss of head control, and potentially fatal respiratory failure.
Image: By Heart
A Pattern of Failure
ByHeart initiated a recall of specific formula lots in November and expanded it three days later to include all its infant formula products. Despite these clear directives, the retailers failed to act:
Walmart was found to have the contaminated formula on shelves in 21 states.
Target not only kept the product available in 20 states but also promoted it with a $2 discount for a full week after the recall was announced.
Employees cited reasons ranging from simple unawareness to confusion over which items needed to be pulled.
Regulatory Response & Next Steps
The FDA has given the companies 15 working days to provide a detailed account of the steps they have taken to correct these violations and prevent future occurrences. The agency has warned that failure to comply could result in severe legal action, including injunction and product seizure. The health and safety of American infants must be prioritized over corporate profit and logistical incompetence.
