FDA Rebukes Retail Giants Over Botulism Formula Recall

The U.S. Food and Drug Administration (FDA) has issued stern warning letters to four of the nation’s largest retailers—Walmart, Target, Kroger, and Albertsons—after they failed to promptly remove recalled ByHeart infant formula from store shelves, despite the product’s link to a dangerous outbreak of infant botulism. The recall, initiated on November 8, 2025, and expanded nationwide just three days later, was triggered after dozens of infants across 19 states developed suspected or confirmed cases of botulism, a rare but potentially deadly illness caused by Clostridium botulinum bacteria.

According to CNN, the FDA’s investigation found that as late as November 26, 2025, the recalled formula was still being sold or displayed at over 175 locations across 36 states. This discovery came after more than 4,000 in-person store checks conducted by federal, state, and local health officials. The agency’s frustration was palpable: “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,” FDA Commissioner Dr. Marty Makary declared in a statement echoed by multiple outlets including States Newsroom and Nexstar Media.

The botulism outbreak, which as of December 10, 2025, had hospitalized 51 infants, prompted the Centers for Disease Control and Prevention (CDC) to expand its case definition to include all babies treated for botulism after consuming ByHeart formula produced since 2023. Thankfully, no deaths have been reported, but the potential consequences remain dire. Infant botulism can cause constipation, poor feeding, loss of head control, difficulty swallowing, drooping eyelids, and, in severe cases, respiratory failure. All affected babies required hospitalization and treatment with intravenous medication to halt the disease’s progression, as reported by the Associated Press and other sources.

The recall’s origins trace back to early November, when ByHeart, a relatively new player in the infant formula market, was notified by the FDA of a possible connection between its Whole Nutrition Infant Formula and several botulism cases. Initially, the company recalled two batches, but after additional cases emerged in babies who had consumed other ByHeart products, the recall was expanded to include all of its formula nationwide. On November 24, ByHeart told parents via its website that it "cannot rule out" contamination across its entire product line, revealing that five out of 36 tested samples were positive for Clostridium botulinum Type A.

Despite these urgent warnings and the recall’s broad scope, the FDA found that compliance among retailers was inconsistent at best. According to FDA warning letters posted online and cited by Food Manufacturing and States Newsroom, Target stores in 20 states continued to display or sell ByHeart formula well after the recall. In one Arkansas Target, single-serve packs were even promoted with a “Sale!” sign and a $2 discount from November 16 to November 22, days after the recall was expanded. In New Hampshire, an investigator purchased recalled formula at a Target on November 16, despite the company’s claim that it had blocked the product’s barcode at registers starting November 11.

Walmart, for its part, had recalled formula on shelves in 21 states between November 12 and November 26, while Albertsons stores in 11 states and Kroger stores in 10 states were also cited for similar failures during overlapping periods. According to the FDA, some retail workers blamed “general stocking issues,” lack of awareness, or confusion about the recall’s specifics. Others admitted uncertainty over which product lots were affected, despite written notifications and repeated outreach from the agency.

The retailers’ responses varied. Walmart, in a statement to CNN and States Newsroom, insisted, “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 echoed this, stating, “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.

But the FDA’s frustration was not limited to the retailers. As Steven Mandernach, executive director at the Association of Food and Drug Officials, told Food Manufacturing, the agency itself was slow to distribute information about the recall to state and local food safety officials, delaying the full product list until November 14—nearly a week after the initial recall. “There probably wasn’t the sense of urgency to ensure the product was off the market that I would expect,” Mandernach said, reflecting broader concerns about the efficiency of the recall process.

The FDA’s letters, signed by top compliance officer Ann Oxenham, gave the companies 15 working days to provide evidence of corrective actions or face potential legal consequences. “These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants,” the agency emphasized in its public statements.

This is not the first time the FDA has had to reprimand retailers for sluggish recall compliance. In 2023, the agency sent a similar warning letter after WanaBana apple cinnamon fruit puree pouches, recalled for lead contamination, remained on store shelves. The pattern raises questions about the effectiveness of current recall notification systems and the preparedness of major retailers to act swiftly when public health is at risk.

ByHeart, for its part, has pledged to continue investigating the root cause of the contamination, promising a “rigorous audit of every step of our product development chain.” The company is issuing refunds for all products purchased on or after August 1, whether bought online or from retailers. Meanwhile, health officials in states from Idaho to Louisiana have issued their own warnings to parents and caregivers, urging them to check for recalled formula and seek medical attention if their babies show any symptoms of botulism.

The stakes could hardly be higher. Infant formula is often a baby’s sole source of nutrition, and the trust parents place in these products—and the stores that sell them—is paramount. As the FDA and industry leaders reckon with the aftermath of the ByHeart recall, the spotlight is now on the entire supply chain to ensure that such lapses do not endanger the nation’s most vulnerable again.

For now, the FDA’s investigation continues, and the agency has made clear that it expects full accountability from every link in the chain, from manufacturers to the biggest names in American retail. The hope is that this episode will prompt lasting improvements in recall compliance and food safety vigilance—because when it comes to infant health, there’s simply no room for error.