The U.S. Food and Drug Administration (FDA) has issued warning letters to Walmart, Target, Kroger, and Albertsons, citing these major retailers for alleged delays in removing recalled ByHeart infant formula from their shelves.
Recall Background
The ByHeart infant formula was subject to a recall initiated on November 11 due to a connection with a botulism outbreak. This outbreak has reportedly affected over 50 infants across 19 states, all of whom have been hospitalized and treated with intravenous medication. The U.S. Centers for Disease Control and Prevention (CDC) has expanded the scope of the outbreak to include all infants treated for botulism after consuming ByHeart formula produced since 2023.
FDA Findings
According to the warning letters, which were dated December 12 and posted online, the companies continued to sell the recalled formula for days or weeks after the November 11 recall notification.
Specific instances cited by the FDA include:
- Target: Formula was reportedly found in stores across 20 states "well after the recall was initiated." One Target store in New Hampshire allegedly sold the product on November 16, despite an electronic sales block. In Arkansas, ByHeart single-serve packs were promoted with a "Sale!" sign and a $2 discount between November 16 and November 22.
- Walmart: Information from state and local health officials indicated ByHeart formula was present in Walmart stores in 21 states from November 12 to November 26.
- Albertsons: The formula was reportedly found in Albertsons stores in 11 states from November 12 to November 19.
- Kroger: ByHeart formula was reported in Kroger stores in 10 states from November 12 to November 19.
Furthermore, the FDA stated that the companies had not provided evidence of corrective actions despite multiple requests. The retailers have been given 15 working days to respond to the letters.
Company Responses
- Walmart issued a statement asserting that no ByHeart formula was sold after cash registers were blocked following the recall. A company spokesperson stated, "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 stated that the company collaborated with suppliers and regulators to identify and remove the products and communicate with customers. The company confirmed, "ByHeart infant formula products have been removed from our store shelves."
Broader Context
Steven Mandernach, Executive Director of the Association of Food and Drug Officials (AFDO), noted that the FDA itself was slow to disseminate recall information to state and local food safety officials. He indicated that the agency did not fully share product lists until November 14, nearly a week after the initial recall of two ByHeart formula lots on November 8. Mandernach described the situation as "disappointing" given the product's role as a sole source of nutrition for vulnerable infants.