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FDA warns major US retailers, including Target and Walmart, for failing to remove recalled infant formula

December 16, 2025
1 min read
FDA warns major US retailers, including Target and Walmart, for failing to remove recalled infant formula

FDA warns major retailers over recalled baby formula linked to botulism

The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger, and Albertsons after the stores failed to remove recalled baby formula linked to a large infant botulism outbreak, reports BritPanorama.

The FDA stated that it had communicated repeatedly with the retailers about the recall, sending multiple emails requesting action plans to comply, but received no responses from the companies. Inspectors conducted over 4,000 store checks, identifying recalled products in over 175 locations across 36 states. Notably, one Target store still had ByHeart formula on the shelves three weeks after the recall notification was issued.

The recall of ByHeart infant formula products began on November 8 and was expanded three days later to include all ByHeart Whole Nutrition Infant Formula products. As of December 10, 51 children in 19 states have experienced suspected or confirmed cases of infant botulism following exposure to these products, leading to hospitalizations without any reported fatalities. The outbreak is still under investigation.

“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,” said FDA Commissioner Dr. Marty Makary. ByHeart has promised a “rigorous audit of every step” in its production process to determine the root cause of the contamination.

In discussions regarding compliance, Walmart spokesperson mentioned, “The health and safety of our customers and members is always a top priority… We take all reports of inaction seriously and will respond to the letter.” Albertsons has asserted its commitment to removing affected items, stating that the ByHeart products have been pulled from its shelves. However, Target and Kroger did not immediately respond to requests for comment.

The FDA has given the companies 15 working days to address remedial actions regarding the issue or face potential legal ramifications. This is not the first instance of compliance difficulties; a similar warning was issued to retailers over another recall in 2023.

The situation underscores the ongoing challenges retailers face in managing product safety and compliance amid a rising tide of health concerns over food products.

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