The botulism outbreak, which has affected over 50 infants across 19 states, has prompted widespread scrutiny of how food safety recalls are managed by both corporations and government agencies. The FDA’s action underlines the critical importance of swift and efficient recall procedures, especially when dealing with products that can have life-threatening consequences for vulnerable populations like infants.
Retailers Fail to Act Quickly Despite Recall
On December 12, 2025, the FDA sent warning letters to Walmart, Target, Kroger, and Albertsons after its investigation found that the retailers continued to sell ByHeart infant formula days or even weeks after a recall was announced in mid-November. According to the FDA, the formula was still available at stores in multiple states well beyond the recall date, posing a significant health risk to babies. The letter accused the companies of failing to remove the tainted product from their shelves and questioned whether any corrective actions had been taken.
At Target, for example, ByHeart formula was found on store shelves in 20 states well after the recall was initiated. In some cases, the formula was sold despite an electronic block on its sales code. Notably, a store in Arkansas even promoted the product with a sale sign offering discounts from November 16 to November 22, 2025.
Similar violations were found at Walmart, where the formula remained on sale in 21 states from November 12 to November 26, and at Kroger and Albertsons in 10 and 11 states, respectively. The retailers have been given 15 working days to respond to the warning letters and outline the steps they are taking to address the issue.
FDA’s Concerns About Food Safety Practices
The FDA’s warning highlights deeper concerns about the effectiveness of current food safety practices. While the agency issued the recall for ByHeart formula on November 11, it took nearly a week for the FDA to distribute critical information about the recall to state and local officials. According to Steven Mandernach, executive director of the Association of Food and Drug Officials, the FDA’s delayed response is disappointing, especially given the potential risks involved when dealing with a product as vital as infant formula.
Mandernach criticized the FDA for not sharing detailed product lists with local authorities until November 14, making it harder for state and local officials to act quickly. “There probably wasn’t the sense of urgency to ensure the product was off the market that I would expect,” Mandernach said. His comments underscore the need for improved communication and a more coordinated effort to safeguard consumer health during food safety emergencies.
The botulism outbreak, which has hospitalized every infant affected, further underscores the potential consequences of lax enforcement during product recalls. According to the Centers for Disease Control and Prevention (CDC), babies who consume formula contaminated with Clostridium botulinum spores can develop symptoms like constipation, weak crying, and muscle weakness, eventually progressing to respiratory arrest if not treated promptly.
Walmart, Target, and Albertsons have responded to the FDA’s letters, claiming that they took prompt action to remove the affected product from store shelves once alerted to the recall. A Walmart spokesperson emphasized that once the company was notified, it blocked sales of ByHeart formula and removed it from both physical and online stores. Albertsons echoed this, confirming that the formula was pulled from all their shelves. However, the FDA has yet to receive sufficient documentation to confirm that corrective actions have been fully implemented, leaving open the possibility of further regulatory action.
