On December 12, 2025, the U.S. Food and Drug Administration issued warning letters to Walmart Inc. and Target Corp. after the retailers continued to sell ByHeart Whole Nutrition Infant Formula that had been recalled for its link to a nationwide infant botulism outbreak. The letters were reported on December 15, 2025, and give the companies 15 working days to respond with corrective actions.
The recall began in November 2025 when ByHeart notified the FDA of contamination in certain lots of its infant formula. On November 11, the recall was expanded to all infant formula products. By the time the FDA sent the letters, 51 infants in 19 states had been hospitalized, though no deaths had been reported. Retailers were notified in November, but the FDA found the recalled products still on shelves at Walmart in 21 states and at Target in 20 states.
Target’s investigation revealed that the retailer had offered a $2 discount on the recalled formula from November 16 to November 22, a practice that violated FDA guidance on handling recalled products. Walmart, meanwhile, removed the product from impacted stores, clubs, and its online platform after notification.
The FDA’s letters warn that failure to comply could result in legal action, including fines, product seizure, and injunctions. In addition to Walmart and Target, the agency sent letters to Kroger and Albertsons for similar violations. The FDA also issued an open letter to the food industry outlining best practices for effective recalls, especially for products intended for vulnerable populations.
Walmart’s 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." The company also stated it would respond to the letter and that it takes “all reports of inaction seriously.”
This regulatory action exposes Walmart to potential legal liability, financial penalties, and reputational harm. The incident highlights weaknesses in the retailer’s recall execution and supply‑chain compliance, prompting a likely acceleration of its recall protocols and increased scrutiny from regulators. The event also underscores the importance of robust traceability, a priority Walmart has been pursuing under FSMA 204, and signals to investors that operational risk remains a material concern.
The FDA’s broader initiative, triggered by this and other recall failures, signals a tightening of enforcement across the industry. Retailers that fail to meet recall obligations may face heightened regulatory oversight, which could affect their operational costs and consumer trust.
In summary, the FDA’s warning letters to Walmart and Target over the recalled baby formula represent a significant regulatory event that could influence Walmart’s compliance strategy, investor perception, and future risk profile.
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