(NewsNation) — The FDA has sent warning letters to four major U.S. retailers for continuing to sell a brand of baby formula linked to a nationwide outbreak of bacterial illness in infants.
In the letters, the FDA said Target, Walmart, Kroger and Albertsons kept the recalled ByHeart brand baby formula on their store shelves even after they were notified of the recall in November.
“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,” FDA Commissioner Marty Makary said in the letter.
The illness, called infant botulism, happens when an infant ingests spores of the bacteria Clostridium botulinum, which can grow in their immature digestive systems and produce toxin. Symptoms include constipation, difficulty swallowing, loss of head control, poor feeding and, in severe cases, infants can develop breathing problems.
As of Wednesday, Dec. 10, there have been at least 51 infants in 19 states who became ill from ByHeart formula dating back to at least December 2023. The affected babies ranged in age from about two weeks to nearly nine months.
ByHeart initially recalled some lots of the formula in November, but the company later expanded the recall to all of its infant formulas, including cans and single-serve stick packs.
At Walmart, the recalled products were found in stores in 21 states. The FDA said officials in Arkansas noticed that Target was offering a $2 discount on the formula from Nov. 16 to Nov. 22. It was found in Target stores across 20 states. The FDA has not specified the number of states where the formula was sold at
The FDA asked the retailers to respond to the letters in 15 days and tell them about the steps they’ve taken to address any violations and how they will prevent future violations. The agency said failure to respond could result in legal action.
