The U.S. Food and Drug Administration (FDA) has sent sharp warning letters to some of the nation’s largest retailers after they failed to remove baby formula linked to a serious infant botulism outbreak. The retailers include Target, Walmart, Kroger, and Albertsons.
According to the FDA, these companies ignored repeated communications about the recall. “Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation’s children from unsafe food,” said FDA Commissioner Dr. Marty Makary.
The recall centers on ByHeart infant formula products. It began on November 8 and expanded three days later to cover all ByHeart Whole Nutrition Infant Formula products.
As of December 10, 51 children across 19 states have experienced suspected or confirmed cases of infant botulism linked to these formulas. All of the affected infants have been hospitalized, though thankfully no deaths have been reported.
Infant botulism is a rare but serious illness. It occurs when Clostridium botulinum bacteria spores grow in a baby’s intestines, releasing toxins that affect the nervous system. Symptoms include constipation, muscle weakness, trouble breathing, difficulty swallowing, poor feeding, and loss of head control. Normally, fewer than 200 cases are reported in the U.S. each year.
ByHeart responded to the crisis with a letter to parents last month, promising a thorough investigation. “We will continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain,” the company said.
Despite repeated FDA notices, inspectors found recalled formula still on store shelves. The agency said this occurred across multiple locations in multiple states, sometimes even three weeks after stores received written recall notifications.
The FDA’s latest checks involved more than 4,000 store visits. Inspectors discovered recalled products in over 175 locations across 36 states. The agency, however, noted that no new reports of recalled formula being on shelves have emerged since November 26.
One concerning example came from a Target store. Not only were recalled ByHeart formula products still for sale, but single-serve “anywhere pack” sticks were being sold at a $2 discount.
When questioned, retail workers offered different explanations for the oversight. Some blamed general stocking issues, confusion about which lots were affected, or simply said they were unaware of the recall—even though written notices had been sent.
Walmart responded to the FDA’s warning with a statement to CNN. “The health and safety of our customers and members is always a top priority,” a spokesperson said. “When notified of the recall, we moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online. We take all reports of inaction seriously and will respond to the letter.”
Albertsons also released a statement, assuring customers that ByHeart infant formula products have been removed from shelves. “We are committed to the health and safety of our customers. We have procedures to address product recalls, including working closely with suppliers and regulators to identify and remove affected items and communicate guidance to customers,” the company said.
Target and Kroger have not provided comments regarding the situation.
The FDA has given all four retailers 15 working days to explain the steps they have taken to comply with the recall. Failure to respond could result in legal action.
This is not the first time the FDA has encountered problems with retailers failing to comply with recalls. In 2023, the agency sent a warning letter to a company after WanaBana apple cinnamon fruit puree pouches were recalled due to lead contamination, but the products were still being sold.
The FDA emphasizes that recalls are a critical part of protecting public health. “Every company in the supply chain must act immediately to remove unsafe products from shelves. Delays can put vulnerable infants at risk,” the agency stated.
Parents and caregivers are being urged to check if they have purchased any ByHeart formula products. If they have, they should stop using the products immediately and follow the guidance provided in the recall notice.
Infant botulism requires immediate medical attention. Symptoms can worsen quickly, so doctors stress the importance of early intervention. Hospitals across affected states are monitoring children closely and providing supportive care.
The FDA continues to monitor the outbreak closely and is working with state and local authorities to ensure all recalled products are removed.
Experts warn that this incident highlights gaps in retailer compliance during recalls. Rapid response is crucial when a product poses life-threatening risks, especially for infants.
ByHeart says it is “committed to transparency and accountability” and continues to work with the FDA to trace the contamination and prevent further cases.
The situation has sparked concern among parents nationwide, many of whom are now more vigilant about checking product recalls before buying baby formula.
Retailers are being reminded that ignoring FDA warnings not only endangers children but also risks legal consequences and public trust.
