FDA Warns Major Retailers Over Recalled Infant Formula

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The U.S. Food and Drug Administration has sent warning letters to major retailers, including Albertsons, Kroger, Target and Walmart, for failing to fully remove recalled ByHeart infant formula products from store shelves.

Recall Linked to Infant Botulism Outbreak

All ByHeart Whole Nutrition Infant Formula products were voluntarily recalled on Nov. 11 after being linked to an outbreak of infant botulism. Federal health agencies say at least 51 infants, ages 2 weeks to 9 months, have been hospitalized across 19 states.

Recalled Products Found on Store Shelves

The FDA said it conducted more than 4,000 retail inspections nationwide and found recalled formula still available in over 175 store locations across 36 states. In one case, the product remained on shelves for more than three weeks after the recall.

Retailers Urged to Improve Recall Practices

The agency stressed that retailers play a critical role in protecting consumers by promptly removing recalled items, especially during public health emergencies involving infant food. Companies have 15 days to respond and explain how they will prevent future violations.

Retailer and Company Responses

Walmart and Albertsons said they acted quickly to remove the recalled products and will respond to the FDA’s concerns. ByHeart said testing found Clostridium botulinum in multiple samples and that it is continuing its investigation while offering refunds to affected customers.

Health Warning for Parents

Health officials urge parents to seek immediate medical care if infants who consumed the formula show symptoms such as poor feeding, weak crying, loss of head control or difficulty swallowing. The multistate investigation remains ongoing.

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