Why did the FDA recall infant formula? Complete details behind the safety concerns explained
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WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)The U.S. Food and Drug Administration (FDA) announced a recall of ByHeart’s Whole Nutrition Infant Formula on November 8, 2025. Two batches of the product have been recalled following an outbreak of infant botulism that may be linked to their consumption.
While no direct link between ByHeart’s infant formula and the recent cases of botulism has been established, the baby nutrition company has proactively recalled its infant formula sold during this time to ensure the highest level of safety.
The FDA’s press release reads:
"ByHeart was notified by the FDA on November 7, 2025, of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point. The FDA has not identified a direct link between any infant formula and these cases, and there is no historical precedent of infant formula causing infant botulism.”
According to the FDA, infant botulism is a rare sickness that occurs when Clostridium botulinum gets into an infant's body and starts producing botulinum neurotoxins in its guts.
Signs of the illness in an affected infant include poor feeding, constipation, low muscle tone, drooping eyelids, sluggish pupils, weak cry, difficulty sulking or swallowing, respiratory difficulty, general weakness, and respiratory arrest.
You can find the batch codes of the affected products on the bottom of the cans:
· Batch Code: 251261P2, Use by: 01 Dec 2026
· Batch Code: 251131P2, Use by: 01 Dec 2026
· UPC: 5004496800
More details on the recall of ByHeart's baby formula
Mia Funt, co-founder and president of ByHeart, stated that the recall stems from the company’s commitment to safety for babies and their parents:
"The safety and well-being of every infant who uses our formula is our absolute highest priority. We take any potential safety concern extremely seriously and act quickly to protect families. As parents ourselves, we understand the concern this news may raise."
Funt added:
"This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents."
Consumers who have the affected products are advised to discard them and seek free replacements from ByHeart.
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