The U.S. Food and Drug Administration sent warning letters to several major retailers for failing to remove recalled baby formula from their shelves after a botulism outbreak.
In early November, the FDA recalled ByHeart baby formula because of a large outbreak of infant botulism. The agency said it communicated repeatedly with Target, Walmart, Kroger and Albertsons, but claimed none of the companies responded to remove the products.
Last week, the agency expanded the recall to all products made by the company, stating investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
As of Dec. 10, 51 children from 19 states have either suspected or confirmed cases of infant botulism after exposure to the product.
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All 51 children have been hospitalized, but no deaths have been reported.
The FDA sent inspectors to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged, but the agency has not released any results from those inspections.
ByHeart says it is investigating the cause of the contamination.
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Infant botulism is a rare but potentially serious illness. Symptoms can include constipation, feeding difficulties, weak muscle tone, drooping eyelids, trouble breathing and, in severe cases, respiratory failure.
