Infant formula recalled for botulism lingered on store shelves across the U.S. for weeks, according to a notice from the U.S. Food and Drug Administration.
“Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall,” the FDA said in a Monday announcement. FDA records show that the warning letters went out to Albertsons, Kroger, Target and Walmart.
This voluntary recall of formula was first announced in November and expanded in December At the time of the expanded recall, federal health officials said the outbreak of infant botulism tied to ByHeart baby formula was to include all illnesses reported since the company began production in March 2022.
“In the weeks following the manufacturer’s voluntary recall of ByHeart infant formula products, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers,” the FDA said Monday. “Through this effort, we found that recalled infant formula continued to be found on store shelves – for over three weeks in one case, in over 175 locations across 36 states.”
There have been no new reports of the formula being found on store shelves since Nov. 26, just before Thanksgiving.
Per the U.S. Centers for Disease Control and Prevention, there is an open investigation into the botulism outbreak. As of Dec. 10, it included 51 cases across 19 states, with 12 added on Dec. 3. No deaths have been reported.
When a baby swallows Clostridium botulinum spores that grow in the gut and make toxin, they can become ill with infant botulism. This condition often starts with constipation but can be followed by difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.
“All 51 infants were hospitalized and treated with BabyBIG,” said the CDC. BabyBIG is an intravenous immune globulin for the treatment of infant botulism.
In its announcement, the FDA said that the fact that it had to send out letters highlights “a concerning problem with recall effectiveness at the retail level.” It also said that retailers should be aware of their legal responsibilities regarding food recalls and noted that a retailer also failed to “adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves,” last year.
On that note, it urged the industry “to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country’s most vulnerable populations – infants and young children.” Furthermore, it asked retailers to respond to the letters within 15 days with specific steps to address violations and prevent violations from recurring or an explanation the retailers might that they are not in violation of the law.
“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,” said FDA Commissioner Marty Makary.