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FDA Warns Major Retailers Over Recalled ByHeart Formula Still on Shelves

The FDA gave four major retailers 15 days to detail corrective steps after inspectors found recalled ByHeart formula on shelves in dozens of states.

Overview

  • FDA warning letters to Target, Walmart, Kroger and Albertsons followed store checks confirming recalled ByHeart infant formula remained for sale after the recall notices.
  • Inspectors documented availability at Target in 20 states, Walmart in 21 states, Kroger-owned stores in 10 states and Albertsons in 11 states during mid to late November.
  • Federal and state teams conducted more than 4,000 store visits and found the product at over 175 locations across 36 states.
  • The CDC reports at least 51 infants hospitalized across 19 states with no deaths, as the investigation into ByHeart-linked infant botulism continues.
  • ByHeart began a recall on Nov. 8 and expanded it on Nov. 11 to all unexpired cans and single-serve sticks after Clostridium botulinum was detected in samples, and officials urge caregivers to stop using the product and seek care if symptoms appear.