Federal regulators say recalled ByHeart baby formula linked to a nationwide botulism outbreak stayed on store shelves weeks longer than it should have, even after retailers were formally notified to pull the products.
In mid November, the Food and Drug Administration began issuing warning letters to several major retailers after investigators allegedly found recalled ByHeart infant formula still being sold. According to a November 15 FDA update, the agency contacted “several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall.”
The recall began Nov. 8 after ByHeart Whole Nutrition Infant Formula was connected to cases of infant botulism. On Nov. 11, the recall expanded to include all ByHeart products, covering unexpired cans and single serve “anywhere pack” sticks. Warning letters dated Dec. 12 were sent to Walmart, Target, Albertsons, and Kroger, stating the companies had received written notice of the expanded recall.
The FDA previously said, “Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, [the bacteria that causes botulism] which is causing infant illness in multiple regions of the country.”
As of December 10, the Centers for Disease Control and Prevention confirmed that 51 infants from 19 states had been hospitalized. No deaths have been reported. The CDC explained, “Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin.” Symptoms can include feeding difficulties, weakness, and loss of head control.
The FDA said investigators conducted more than 4,000 retail checks nationwide and found recalled formula in over 175 locations across 36 states. “These warning letters highlight a concerning problem with recall effectiveness at the retail level,” the agency stated.
Retailers have 15 working days to respond. Walmart said, “The health and safety of our customers and members is always a top priority.” Albertsons said it removed the products and follows recall procedures.
ByHeart co founder Mia Funt said, “The safety and well being of every infant who uses our formula is, and always will be, our highest priority.” The company urged parents to stop using all ByHeart formula immediately while investigations continue.
