NEED TO KNOW
A Nov. 15 news release from the FDA revealed they had 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" of the product
The FDA shared on Nov. 8 that they were recalling ByHeart Whole Nutrition Infant Formula had been recalled after being linked to several cases of infant botulism
On Nov. 11 the recall was expanded to include all ByHeart products
Warning letters have been sent out to four major retailers, including Walmart and Target, after an infant formula was reportedly found on shelves despite it being recalled.
The Food and Drug Administration (FDA) announced in a Nov. 8news releasethat ByHeart Whole Nutrition Infant Formula had been recalled after being linked to several cases of infant botulism,PEOPLE previously reported.
The recall was then expanded to include all ByHeart formula products, including all unexpired formula cans and single-serve "anywhere pack" sticks, on Nov. 11, per warning letters sent by the FDA toWalmart, Inc.,Target Corporation,The Albertsons Companies IncorporatedandThe Kroger Company, which were dated Dec. 12. The letters noted that the retailers had been notified in writing about the recall on Nov. 11.
TheFDA had previously saidin an update on Nov. 20 of the outbreak, "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."
In aDec. 10 post, the Centers for Disease Control and Prevention (CDC) confirmed that as of that date, a total of 51 sick infants from 19 states had been hospitalized amid the outbreak, per a news release. No deaths have been reported.
According to the CDC, "Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin."
"Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control," it added.
The FDA noted in a Dec. 15news releasethat warning letters had been sent out last week "to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall."
"These warning letters highlight a concerning problem with recall effectiveness at the retail level," the release added.
The FDA said, "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."
"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," the release continued.
"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," it said.
The warning letters noted that the infants affected ranged from 16 to 264 days of age, with each individual letter noting the dates that the products had been found in the stores after the recall.
The letter to Walmart stated that the products had been found on shelves in stores across 21 states after the recall from Nov. 12 to Nov. 26, while the formula was found in Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19.
Meanwhile, the letter to Target stated that the formula had remained available for purchase on shelves in stores across 20 states from Nov. 12 to Nov. 20, "well after the recall was initiated and subsequently expanded."
"During a recall audit check by an FDA investigator on November 17, 2025, our investigator was informed of a can of the recalled ByHeart infant formula being sold from a New Hampshire Target store on November 16, 2025," the letter included.
The letter also noted that Arkansas state partners had "observed ByHeart Whole Nutrition Infant Formula single-serve 'anywhere pack' sticks on a Target store shelf with promotional 'Sale!' signage offering a $2.00 discount on the recalled formula from November 16 to November 22, 2025."
The letters sent last week suggested that all four retailers had failed to provide the FDA "with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale."
The companies have 15 working days to respond to the letters.
A Walmart spokesperson said in a statement obtained by PEOPLE, "The health and safety of our customers and members 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."
Meanwhile, Albertsons Companies shared in a statement to PEOPLE that 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. ByHeart infant formula products have been removed from our store shelves," the statement added,
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Mia Funt, Co‑Founder and President of ByHeart, said in astatement, "The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority."
"This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve," Funt added, per a Nov. 11 news release.
ByHeart added in a further statement obtained by PEOPLE that the "investigations into the root cause of the outbreak remain ongoing."
"As part of our commitment to identifying a root cause, we have continued to conduct third-party lab testing of ByHeart formula samples. As of the latest update, lab tests have identified Clostridium botulinum in select samples of our formula," the statement added.
It continued, "The investigation includes a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. We have shared our findings with FDA and are continuing to work with regulators to understand how this bacterium entered the food supply."
The company insisted it had "notified all retail partners to remove all ByHeart formula from their shelves," adding, "After the initial two batch recall on November 8, 2025, ByHeart notified retailer partners multiple times, and we have confirmed communication has been sent to stores. FDA also shared notifications with retailers."
Urging parents and caregivers to "stop using all ByHeart formula immediately" and to "monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms," the company concluded, "Our hope is that the findings of these investigations lead to solutions for our own processes and the infant formula industry at-large."
Target Corporation and The Kroger Company didn't immediately respond when contacted by PEOPLE for comment.
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NEED TO KNOW A Nov. 15 news release from the FDA revealed they had sent warning letters to "several major retailers for failing to re...
