That camping trip your family still talks about? Science says it’s worth more than any toy under the tree.
When the FDA issues a recall notice, they expect retailers across the country to act swiftly.
If swift action doesn't occur, the FDA issues its own additional warning.
On Dec. 12, the FDA sent urgent warnings to four major retailers in the United States — Target, Walmart, Kroger and Albertsons — regarding the ByHeart formula recall.
According to the letters, these four retailers didn’t act fast enough when pulling the formula from shelves.
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In one letter, the FDA claimed that ByHeart infant formula was available for purchase in Target stores across 20 states “well after the recall was initiated” — and even sold in multiple locations.
The FDA accused Target of selling one can of ByHeart formula in New Hampshire on Nov. 16 — eight days after the initial voluntary recall and five days after the FDA expanded its initial recall.
Target was also accused of holding a sale on ByHeart infant formula, which included a $2 discount, from Nov. 16-22.
The FDA also found ByHeart formula in Walmart stores across 21 states between Nov. 12 and 26, Albertsons stores in 11 states from Nov. 12 to 19 and Kroger stores in 10 states from Nov. 12 to 19.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” the FDA wrote in each of the letters.
“You should take action to immediately remove the affected product from distribution and sale, cease all further shipment or use, and implement all necessary measures to prevent further exposure,” they added.
The FDA recalled all ByHeart formula products in early November
The ByHeart recall began on Nov. 8 when the company voluntarily recalled two batches of its ByHeart Whole Nutrition Infant Formula after the FDA notified them of a recent outbreak of infant botulism.
According to the Cleveland Clinic, infant botulism “is a rare, life-threatening condition that can cause a slow form of paralysis in infants” who ingest a certain type of bacteria known as Clostridium botulinum.
Common symptoms include constipation, poor feeding, drooping eyelid, sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness and respiratory difficulty.
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The recall coincides with an ongoing FDA investigation into 84 cases of infant botulism since August.
As the number of cases grew, the FDA recommended that ByHeart expand its initial recall — and it did.
On Nov. 11, ByHeart formula recalled 100% of its unexpired products sold nationwide — including its Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula.
As of Dec. 10, the CDC reported that 51 infants from 19 states have suspected or confirmed infant botulism — and ByHeart formula was determined to be the source of the infant botulism outbreak.
Cases were initially reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, per the report.
Since then, seven more states — Idaho, Wisconsin, Michigan, Ohio, Virginia, Massachusetts and Maine — have been affected by the outbreak.
Parents who have ByHeart formula in their household are being urged to:
- take a photo or record the information on the bottom of the package.
- keep the container in a safe spot and be sure to label that product as DO NOT USE.
- If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism, seek medical help immediately. Infant botulism can be fatal if not acted upon.
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“FDA has not received reports of recalled formula being found on store shelves since November 26, 2025,” the FDA wrote in its most recent Dec. 10 update.
