FDA: Retailers In Michigan Warned For Selling Recalled Formula

Many Michigan families rely on baby formula to provide their babies with the nutrients they need to grow and thrive. However, major retailers in Michigan have received official warnings for affecting families after continuing to sell formula linked to a botulism outbreak.

FDA: Retailers In Michigan Warned For Selling Recalled Formula

The U.S. Food and Drug Administration (FDA) issued warning letters to four of America's largest retailers in Michigan after finding infant formula linked to a botulism outbreak remained available for purchase well after an official recall was announced in November. The FDA said the named companies have not provided evidence that corrective actions were implemented, despite repeated requests.

Get our free mobile app

The recall of ByHeart infant formula products started on November 8 and was expanded three days later to include all ByHeart Whole Nutrition Infant Formula products. Warning letters have been sent out to major retailers, including Target, Walmart, and Kroger. The warning letters give each 15 working days to respond with a remedy or explanation. Failure to address the issue could lead to further regulatory action.

As of December 10, 51 children from 19 states have had suspected or confirmed cases of infant botulism after confirmed exposure to these products. All 51 have been hospitalized, but no deaths have been reported. The outbreak investigation remains ongoing.

ByHeart said in a letter to parents last month that it will “continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain.”