• FDA warns Walmart, Target, Kroger, and Albertsons for slow response to ByHeart formula recall.
• Recalled formula was found in stores weeks after the recall was initiated.
• Company ByHeart recalled all products after testing positive for harmful bacteria.
• Over 50 infants in 19 states affected by the botulism outbreak.
• Retailers have 15 days to respond to FDA’s warning letters.

The U.S. Food and Drug Administration (FDA) has expressed strong concerns regarding the slow response of four major retailers—Walmart, Target, Kroger, and Albertsons—in removing ByHeart infant formula linked to a dangerous botulism outbreak from their shelves. The FDA sent warning letters stating that these retailers continued to sell the contaminated formula days after a recall was issued on November 11, despite being notified of the outbreak that affected over 50 infants in 19 states, according to NPR and CBS News.

Specifically, the FDA found ByHeart formula at Target locations across 20 states and in Walmart stores in 21 states, well after the initiation of the recall. The situation was exacerbated by promotions at some Target stores, where the recalled formula continued to be sold at a discount. The companies failed to provide adequate evidence of the corrective actions taken to address the issue, leaving them with a 15-working-day deadline to respond to the FDA's warning, as reported by The Hill and CBS News.

This recall began after ByHeart initially recalled two batches of its Whole Nutrition infant formula on November 8, prompted by the FDA's notification of a link to several cases of infant botulism. ByHeart later expanded the recall to all its products as subsequent cases surfaced. The most recent findings indicated that the company could not rule out contamination across all of its infant formulas, according to NPR, The Hill, and CBS News.

The FDA's criticism also highlighted the need for retailers to strengthen their compliance practices, especially when it comes to recalls. Many retailers were reportedly unsure about the specifics of the recall and failed to act accordingly. According to Donald Prater, the FDA's principal deputy director for human foods, the agency found recalled formula at over 175 retail locations across 36 states, demonstrating a critical need for improved communication and adherence to recall protocols, as outlined in statements by NPR and The Hill.