by Federal regulators are warning some of the nation’s largest retailers after finding that recalled baby formula tied to a deadly botulism outbreak was still being sold months after the recall began.
The U.S. Food and Drug Administration (FDA) has issued formal warning letters to Target, Walmart, Albertsons, and Kroger, stating that stores across multiple states continued selling recalled infant formula despite repeated notifications.
The warnings are connected to a multi-state recall of ByHeart Whole Nutrition Infant Formula, first announced in August, after dozens of infants became seriously ill.
Recalled formula linked to infant botulism cases
According to the Centers for Disease Control and Prevention (CDC), at least 51 infants in 19 states developed infant botulism after being fed the recalled ByHeart formula. The investigation into the outbreak is still ongoing.
Infant botulism is a rare but potentially fatal illness caused by Clostridium botulinum bacteria, which can produce toxins affecting the nervous system. The FDA warns that without prompt treatment, the condition can be life-threatening.
Despite the recall, FDA inspections found that the affected formula products remained available for purchase through at least November, well after the recall had been expanded.
FDA says retailers failed to act quickly
In its warning letters, the FDA stressed that retailers play a critical role in protecting consumers once a recall is issued.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” the FDA wrote. “Affected products must be immediately removed from distribution and sale to prevent further exposure to consumers.”
The agency said that continued sales occurred despite multiple recall notifications being sent to retailers.
Target stores flagged in multiple states
The FDA reported that recalled formula was found on shelves in at least 20 Target stores nationwide.
In one instance, single-serve packs of the recalled formula were even marked with a promotional “Sale!” sign, according to the agency.
State and local inspectors cited several explanations from store employees, including:
- Lack of awareness of the recall
- Confusion about which product lots were affected
- Failure to remove all recalled inventory
- Restocking products that arrived after recall notices were issued
The FDA described these failures as serious violations of recall procedures.
Walmart, Albertsons, and Kroger also named
The agency said similar issues were found at other major retailers:
- Walmart: Recalled formula discovered in stores across 21 states
- Albertsons (including Jewel-Osco): Products found in 11 states
- Kroger-owned stores: Recalled items located in 10 states
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The FDA instructed each retailer to respond in writing within 15 days, detailing the steps taken to remove recalled products and prevent future violations.
Albertsons responds to FDA warning
In a statement provided to media outlets, Albertsons Companies said it has removed ByHeart infant formula from its shelves.
“At Albertsons Companies, we are committed to the health and safety of our customers,” the company said.
“We have procedures to address product recalls, including working closely with suppliers and regulators to identify and remove affected items.”
Other retailers named in the warning letters have not publicly commented on the FDA’s findings as of now.
What parents should know about infant botulism
The FDA urges parents and caregivers to be alert for symptoms of infant botulism, which may include:
- Constipation
- Poor feeding
- Drooping eyelids
- Sluggish pupils
- Low muscle tone
- Difficulty sucking or swallowing
- Weak or altered cry
- Generalized weakness
- Breathing difficulties or respiratory arrest
Medical officials stress that early treatment is critical and that parents should seek immediate medical care if symptoms appear.
Formula supply not expected to be affected
Despite the seriousness of the outbreak, the FDA says the recall will not impact the national infant formula supply.
ByHeart products account for less than 1% of all infant formula sold in the U.S., and regulators do not expect the recall to contribute to shortages.
Are other formula brands involved?
Since August, the FDA has received 83 reports of infant botulism potentially linked to formula feeding. However, the agency has not identified any additional brands publicly at this time.
Officials say investigations are ongoing, and additional information may be released as testing and case reviews continue.
What consumers should do now
The FDA advises parents and caregivers to:
- Check their homes for recalled formula
- Stop using any affected products immediately
- Return recalled items to the store or dispose of them safely
- Consult a healthcare provider if an infant shows symptoms
Retailers are also being reminded that failure to follow recall protocols can put lives at risk.
As the investigation continues, federal officials say enforcement actions may follow if compliance does not improve.
Have you been affected by a product recall that wasn’t clearly communicated? Share your experience in the comments below.
