The U.S. Food and Drug Administration has issued formal warning letters to four of the nation’s largest grocery and retail chains—Walmart, Target, Kroger, and Albertsons—after determining that the companies continued selling recalled baby formula tied to a nationwide outbreak of infant botulism. According to the FDA, the retailers failed to promptly remove affected products from store shelves despite being notified of the recall weeks earlier.
The warning letters, dated December 12 and published on the FDA’s website this week, mark a significant escalation in the agency’s response to what it described as serious violations of federal food safety regulations. The products in question involve ByHeart Whole Nutrition Infant Formula, which was recalled in November following reports linking it to a growing number of severe bacterial infections in infants.
The FDA said the continued availability of the recalled formula placed vulnerable consumers—particularly newborns and young infants—at unnecessary risk during an ongoing public health investigation.
Recalled Formula Remained on Shelves Nationwide
According to the agency, Walmart, Target, Kroger, and Albertsons were all notified of the recall but nonetheless allowed the formula to remain available for purchase in numerous locations across the country.
At Walmart, FDA inspectors found recalled ByHeart formula still being sold in stores across 21 states. Target locations in 20 states also carried the recalled products well after the recall notice was issued. Kroger and Albertsons similarly failed to fully remove affected inventory from their shelves, the agency said.
In one instance cited in the warning letters, FDA officials reported that Target stores in Arkansas were actively promoting the recalled formula by offering a $2 discount between November 16 and November 22—days after the company had been informed of the recall. The FDA said this action raised particular concern, as it could have encouraged consumers to purchase a product that had already been deemed potentially dangerous.
The regulator emphasized that retailers play a critical role in recall effectiveness and that delays or breakdowns at the store level can undermine efforts to protect public health.
Infant Botulism Outbreak Raises Alarm
The recall stems from an outbreak of infant botulism, a rare but potentially life-threatening illness that affects babies when they ingest spores of the bacterium Clostridium botulinum. Unlike older children and adults, infants have underdeveloped digestive systems that allow the spores to grow and produce a powerful neurotoxin.
Symptoms of infant botulism can include constipation, weak crying, poor feeding, reduced muscle tone, loss of head control, and difficulty swallowing. In severe cases, the toxin can interfere with breathing, requiring hospitalization and mechanical ventilation.
As of last week, the Centers for Disease Control and Prevention reported that 51 infants across 19 states had been sickened in the outbreak. The affected children ranged in age from approximately two weeks to nearly nine months old. While most infants recover with prompt medical treatment, the illness can be devastating for families and places significant strain on pediatric intensive care units.
Federal health officials have not publicly disclosed whether all confirmed cases were directly linked to ByHeart products, but the FDA said the recall was initiated out of an abundance of caution as investigators continue to analyze samples and illness reports.
Recall Expanded to All ByHeart Formula Products
ByHeart, a New York–based infant formula company, initially recalled specific lots of its Whole Nutrition Infant Formula in mid-November. Just three days later, the company expanded the recall to include all of its infant formula products after additional concerns emerged.
The expanded recall covered both traditional cans and single-serve stick packs, significantly increasing the scope of products that retailers were required to remove from shelves. The FDA said this information was communicated clearly to distributors and retailers through established recall notification channels.
Despite those notifications, inspectors later found that store-level implementation was inconsistent, with recalled products sometimes remaining alongside non-affected formula brands.
Store-Level Confusion Cited
In its warning letters, the FDA said interviews with store employees revealed a range of explanations for why the recalled formula was not promptly removed. Some workers said they were unaware of the recall altogether, while others cited confusion over which specific products were affected. In several cases, employees acknowledged that not all impacted inventory had been identified or removed.
The agency noted that such lapses point to systemic weaknesses in recall response procedures rather than isolated mistakes. Federal regulations require retailers to take swift and comprehensive action once they are notified that a product they sell has been recalled due to safety concerns.
“The failure to ensure recalled products are removed from commerce is a serious violation,” the FDA said, warning that inadequate recall execution can expose consumers to significant harm.
FDA Demands Corrective Action
The warning letters give Walmart, Target, Kroger, and Albertsons 15 working days to respond in writing and detail the steps they have taken to prevent similar violations in the future. The retailers are expected to outline improvements to their recall management systems, employee training programs, and internal communications.
The FDA cautioned that failure to adequately address the violations could lead to enforcement actions, including product seizures or court injunctions that would prevent the companies from selling certain items.
While warning letters do not carry immediate penalties, they are often a precursor to stronger regulatory action if problems persist.
Broader Implications for Food Safety Oversight
The incident highlights ongoing challenges in the U.S. food safety system, particularly when recalls involve products intended for infants and other vulnerable populations. Public health experts have long stressed that recall effectiveness depends not only on manufacturers issuing notices, but also on retailers executing removals quickly and uniformly across thousands of stores.
Consumer advocates say the FDA’s action underscores the need for tighter oversight and more transparent accountability when recalls involve essential products such as infant formula, which many families rely on daily.
The warning letters also come amid continued scrutiny of the infant formula supply chain following shortages and safety concerns that have plagued the industry in recent years.
For parents and caregivers, federal health officials continue to advise checking recall notices carefully and avoiding any ByHeart infant formula products included in the recall. Consumers who have purchased the affected formula are encouraged to stop using it immediately and consult healthcare providers if their infant shows any symptoms of illness.
As the investigation into the outbreak continues, the FDA said it remains committed to working with state and federal partners to protect infant health and ensure that recalled products are removed swiftly from the marketplace.
Emily Johnson is a critically acclaimed essayist and novelist known for her thought-provoking works centered on feminism, women’s rights, and modern relationships. Born and raised in Portland, Oregon, Emily grew up with a deep love of books, often spending her afternoons at her local library. She went on to study literature and gender studies at UCLA, where she became deeply involved in activism and began publishing essays in campus journals. Her debut essay collection, Voices Unbound, struck a chord with readers nationwide for its fearless exploration of gender dynamics, identity, and the challenges faced by women in contemporary society. Emily later transitioned into fiction, writing novels that balance compelling storytelling with social commentary. Her protagonists are often strong, multidimensional women navigating love, ambition, and the struggles of everyday life, making her a favorite among readers who crave authentic, relatable narratives. Critics praise her ability to merge personal intimacy with universal themes. Off the page, Emily is an advocate for women in publishing, leading workshops that encourage young female writers to embrace their voices. She lives in Seattle with her partner and two rescue cats, where she continues to write, teach, and inspire a new generation of storytellers.
