Dec 16, 2025
The U.S. The Food and Drug Administration is warning four major retailers about compliance with a recall of infant formula that has been linked to botulism.  Ann Oxenham, the FDA’s top compliance officer for the human foods program, sent letters to Albertsons, Kroger, Target and Walmart Friday about ByHeart Whole Nutrition formula products remaining on some store’s retail shelves as late as Nov. 26.  “These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants,” the agency said in a statement released Monday.  No infant deaths attributed to the outbreak have been reported. At least 51 cases across 19 states resulted in infant hospitalizations as of Dec. 10, according to the Centers for Disease Control and Prevention. ByHeart issued a recall of the formula on Nov. 8. The company expanded the recall three days later to include all of its products, including unexpired formula cans and single-serve “anywhere pack” sticks, according to an agency news release.  When the agency’s state and local partners made 4,000 visits to retail stores in the weeks after the initial recall, they found the formula stocked at more than 175 locations across 36 states.  “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 a statement.  Botulism in babies occurs when a baby swallows Clostridium botulinum bacteria, according to the CDC. Symptoms can take weeks to develop, but they include constipation, poor feeding, loss of head control and difficulty swallowing.  The ByHeart formula products were found at Walmart stores in 21 states from Nov. 12 to Nov. 26, according to the FDA warning letter to CEO Doug McMillon.  “As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” Oxenham wrote.  A Walmart spokesperson told States Newsroom that the health and safety of their customers is “always a top priority.”  “When notified of the recall, we moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online. We take all reports of inaction seriously and will respond to the letter,” the spokesperson said.  Even though Target told the FDA that the big-box store put a block on bar codes for cans of ByHeart formula and the single-serve packs on Nov. 11, an investigator found the formula at a New Hampshire location five days later, according to the warning letter.  A larger agency audit discovered the recalled formula was still on Target shelves across 20 states from Nov. 12 to Nov. 20. Associates told state and local FDA partners that they were not aware of the recall or confused about the scope of which products were potentially affected by the contamination, among other explanations.  An auditor even found the single-serve formula packs marked down at an Arkansas Target with a $2 discount weeks after the nationwide recall, the letter states.  Target did not immediately respond to a request for comment.  The recalled formula was found at several Albertsons stores, including Acme and Safeway, across 11 states from Nov. 12 to Nov. 19, according to an FDA letter sent to CEO Susan Morris. Agency officials had a call with the company’s leadership on Nov. 20 asking for a plan about the issue, but Oxenham wrote that the company did not deliver one. In a statement provided to States Newsroom, a spokesperson for the company said “they are committed to the health and safety of our customers.”  “We have procedures to address product recalls, including working closely with suppliers and regulators to identify and remove affected items and communicate guidance to customers,” a spokesperson said. “ByHeart infant formula products have been removed from our store shelves.”  The FDA wrote to Kroger interim CEO Ronald Sargent on Friday, too, saying that the formula was found at the company’s stores across 10 states “well after the recall was initiated and subsequently expanded.” Kroger did not immediately respond to a request for comment.  ByHeart is issuing refunds for all products purchased on or after Aug. 1 from their website, and parents or caregivers can also get their money back if they purchased the formula from retailers, according to a statement.  The company has had safety issues recently: A Pennsylvania plant closed this year after inspectors found mold, dead insects and a leaking roof in a formula production area, The New York Times reported last month.  Two years ago, a hazardous bacterium that can cause sepsis and meningitis in infants was found in a processing area of the same plant and in finished formula shortly after, according to the Times.  Health officials in Idaho, Louisiana, Minnesota, New Mexico and countless other states have issued warnings about the ByHeart formula recall. This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Kentucky Lantern, and is supported by grants and a coalition of donors as a 501c(3) public charity. The post Major retailers slow to remove recalled infant formula from shelves, FDA says appeared first on The Lexington Times. ...read more read less
Respond, make new discussions, see other discussions and customize your news...

To add this website to your home screen:

1. Tap tutorialsPoint

2. Select 'Add to Home screen' or 'Install app'.

3. Follow the on-scrren instructions.

Feedback
FAQ
Privacy Policy
Terms of Service