About three-quarters of U.S. infants receive formula by six months, according to federal health data — which means a quick pantry check might matter more than you think.
On Tuesday, November 11, the U.S. Food and Drug Administration (FDA) announced that ByHeart, a baby formula company based in New York, is recalling every batch of its Whole Nutrition Infant Formula nationwide. The move comes after federal health officials connected the brand to a growing outbreak of infant botulism, a rare but serious illness that can affect babies under one year old.
RECALL UPDATE: All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. t.co/umKvtkXgtI pic.twitter.com/ABTAUPo8jC
— U.S. FDA (@US_FDA) November 11, 2025Here’s the quick rundown:
15 infants across 12 states have been hospitalized since AugustThe bacteria in question is Clostridium botulinum — the same one that causes botulismThe FDA says no unopened cans have tested positive so farByHeart says it’s now testing every batch of formula through an independent third-party labThe recall includes all unexpired 24-oz cans and single-serve “Anywhere Pack” sticksThe company first pulled two batches off shelves on November 8 after California health officials found possible signs of contamination in an open can from a sick baby’s home. A few days later, ByHeart decided to recall everything still within its expiration window.
That doesn’t mean every can is contaminated. The FDA says unopened cans haven’t shown any trace of the bacteria, but the agency is urging parents who use ByHeart to stop feeding it to their babies until further notice.
A recall of ByHeart baby formula tied to botulism is expanding after two more infants were hospitalized. @RhiannonAlly has the latest. pic.twitter.com/bqsHvjleeJ
— Good Morning America (@GMA) November 12, 2025? SIGN UP for Parade's Daily newsletter to get the latest pop culture news & celebrity interviews delivered right to your inbox ?
In a statement, ByHeart co-founder and president Mia Funt said the decision was made “in close collaboration with the FDA” and emphasized that it’s a precautionary move. “The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” she said.
If you’ve been using ByHeart, stop immediately. Take a quick photo of the can showing the lot number and “use by” date and set it aside for now. Watch for any warning signs like constipation, weak or altered cry, trouble swallowing, loss of head control, or breathing issues. According to the CDC, symptoms can develop slowly — sometimes over several weeks — so call your doctor right away if something feels off.
If your baby’s fine, there’s no need to panic. Don’t keep using the formula, but hang onto the container itself for about a month in case health officials request it for testing. If your baby stays symptom-free after that, you can safely toss it.
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As for the supply side, the FDA has confirmed this recall won’t cause another shortage. ByHeart represents less than one percent of the U.S. formula market, so there’s plenty of product from other brands on shelves nationwide.
Parents with questions can reach ByHeart at [email protected] or 1-833-429-4327.
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