The Food and Drug Administration (FDA) stated in a statement that ByHeart Inc. has agreed to start recalling two lots of the company’s Whole Nutrition Infant Formula.
The recall covers cans marked with batch codes 251261P2 and 251131P2, both with a “Use by” date of Dec. 1, 2026. The business indicated that UPC 5004496800 is the only batch that is affected and said no other batches are affected. No ByHeart product has tested positive for contaminants, ByHeart said.
ByHeart said the FDA notified the company on Nov. 7 of an estimated 83 infant botulism cases reported nationwide since August; 13 of those infants had received ByHeart formula at some point. The FDA has not identified a direct link between any infant formula and the illnesses, the company added.
Co-Founder and President Mia Funt said, “The safety and well-being of every infant who uses our formula is our absolute highest priority.” She also said that the recall is a precaution to “remove any potential risk from the market,” as quoted by ByHeart.
Consumers should stop using and dispose of cans from the listed batches. Parents should contact a health care provider immediately if infants show symptoms consistent with infant botulism, which can include constipation, poor feeding, weak or altered cry, low muscle tone, and breathing difficulties, ByHeart said
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