On December 12, 2025, the U.S. Food and Drug Administration (FDA) issued stern warning letters to four of the nation’s largest retailers—Walmart, Target, Kroger, and Albertsons—after inspectors repeatedly found recalled ByHeart baby formula still on store shelves, weeks after a nationwide recall linked to a serious infant botulism outbreak. The FDA’s investigation, conducted alongside state and local partners, uncovered the recalled formula in over 175 locations across 36 states, sometimes as late as three weeks after written recall notifications had been sent to the companies, according to multiple reports from CNN, The New York Post, and Local 3 News.
The recall saga began on November 8, 2025, when ByHeart initiated a voluntary recall of its Whole Nutrition Infant Formula following the discovery of Clostridium botulinum spores in certain batches. The recall was expanded just three days later to include all ByHeart Whole Nutrition Infant Formula products. Despite the urgency and scope of the recall, FDA inspectors continued to find the product on shelves well into late November, a lapse that regulators say put infants’ health at grave risk.
Infant botulism is a rare but potentially fatal illness caused by the ingestion of C. botulinum spores, which can colonize an infant’s gut and produce dangerous neurotoxins. According to the Centers for Disease Control and Prevention (CDC), as of December 10, 2025, 51 infants from 19 states had suspected or confirmed cases of infant botulism after exposure to ByHeart formula. All 51 children were hospitalized, though, fortunately, no deaths have been reported so far. Early symptoms of infant botulism include constipation, poor feeding, loss of head control, and difficulty swallowing, with the illness sometimes progressing to respiratory failure, the CDC notes.
The FDA’s letters, sent to the leadership of each retailer, were unequivocal in their criticism. “Once your firm has been made aware of a recall or potential safety issue, you should take action to immediately remove the affected product from distribution and sale, cease all further shipment or use, and implement all necessary measures to prevent further exposure to consumers or downstream distribution,” the agency wrote, as reported by Stocktwits and CNN. The agency emphasized that keeping recalled products on shelves is a violation of federal law and warned that failure to comply could result in seizure, injunction, or other legal action.
Inspectors found that Walmart, in particular, had recalled ByHeart formula on shelves in stores across 21 states from November 12 through November 26, 2025, even after the recall was expanded. According to the FDA, Walmart store associates offered a range of explanations for the continued presence of the recalled product, from lack of awareness of the recall notice to confusion about which specific lots were affected. The FDA noted in its letter to Walmart CEO Doug McMillon that, despite multiple follow-up emails and a call with company leadership, Walmart failed to demonstrate it had taken sufficient corrective action.
Target faced similar scrutiny. The FDA determined that recalled formula was available at Target locations in 20 states from November 12 to November 20, 2025, despite the company’s claim that it had electronically blocked the affected products. In one particularly egregious case, investigators found ByHeart Whole Nutrition Infant Formula single-serve “anywhere pack” sticks for sale at a $2 discount in a Target store after the recall notice had been issued. The FDA’s letter to Target underscored that discounted sales of a recalled product only increased the risk of exposure to consumers.
Kroger, which operates stores under several banners including King Soopers and Smith’s, was cited for having recalled formula on shelves in 10 states between November 12 and November 19, 2025. Albertsons, along with its subsidiaries Safeway, Jewel-Osco, Acme, Star Market, and Shaw’s, was flagged for similar failures in 11 states, with recalled formula available days after both the initial and expanded recall notifications.
Retail workers across all four chains cited a variety of issues for the ongoing sales of the recalled formula: stocking problems, lack of recall awareness, and confusion over which lots were affected. The FDA, however, was unsympathetic to these explanations, reiterating that “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,” as stated by FDA Commissioner Dr. Marty Makary in a statement to CNN.
Inspectors conducted more than 4,000 store checks as part of the investigation. The FDA said it had not received reports of recalled formula being on store shelves since November 26, but the agency remains vigilant, noting that the investigation into the outbreak is ongoing. Officials are continuing to analyze unopened formula samples, and they caution that negative test results do not necessarily rule out contamination, given the difficulties in detecting C. botulinum spores.
All four retailers were given 15 working days from the receipt of the warning letters to respond in writing with details of the steps they are taking to address the violations and prevent future occurrences. The FDA made clear that immediate removal of dangerous products is “essential” to preventing further exposure and that retailers are responsible for acting swiftly once notified of a recall.
In response to the FDA’s findings, Walmart stated, “The health and safety of our customers and members is always a top priority. 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 issued a similar statement: “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. ByHeart infant formula products have been removed from our store shelves.” Target and Kroger did not immediately respond to requests for comment, according to CNN and The New York Post.
ByHeart, the manufacturer at the center of the recall, has stated that it will “continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain.” The company’s recall remains in effect nationwide as the investigation continues.
This episode is not the first time the FDA has encountered challenges with recall compliance. In 2023, the agency sent a similar warning letter to a retailer that failed to remove recalled WanaBana apple cinnamon fruit puree pouches due to lead contamination concerns. The FDA’s ongoing struggle to enforce recall protocols highlights a broader issue in the U.S. food supply chain—ensuring that safety warnings are acted upon swiftly and comprehensively to protect vulnerable consumers, especially infants.
As the investigation unfolds, the FDA’s message is clear: food safety lapses that risk the lives of children will not be tolerated, and all parties in the supply chain must remain vigilant and responsive to recall protocols—no exceptions.
