ByHeart recalls all batches of its Whole Nutrition Infant Formula after detecting Clostridium botulinum
31 cases of suspected or confirmed infant botulism linked to the formula have been reported across 15 states
Parents are urged to stop using the product immediately and monitor infants for symptoms
ByHeart has issued a sweeping voluntary recall of every batch of its Whole Nutrition Infant Formula, sold both in 24-ounce cans and in its Anywhere Pack single-serve packets, after the company’s testing detected Clostridium botulinum in some samples.
The announcement comes amid a federal investigation into a multistate outbreak of infant botulism affecting at least 31 babies.
The company said the recall is being carried out in coordination with the U.S. Food and Drug Administration (FDA) and reflects its “commitment to protecting babies above all else.” ByHeart initially recalled two lots of infant on Nov. 10 “out of an abundance of caution,” adding that none of its formula had tested positive for botulism.
What triggered the recall
According to ByHeart, the action follows an ongoing investigation into a rise in infant botulism cases. During its own third-party testing, conducted with food safety laboratory IEH, the company found evidence of C. botulinum, a bacterium capable of causing life-threatening illness. Those findings were immediately reported to federal regulators.
Although infant botulism is rare, it can be severe. Illness occurs when babies ingest spores that then colonize in the gut and release dangerous neurotoxins.
Early symptoms may include constipation, weak sucking, poor feeding, a weak or unusual cry, sluggish pupils, reduced muscle tone, drooping eyelids, and breathing difficulties. All 31 affected infants have required hospitalization, but no deaths have been reported.
Cases under investigation stretch from August 9 to November 13, 2025, and involve infants between 16 and 200 days old across 15 states. Nearly half of the babies for whom sex was reported are female.
Products included in the recall
ByHeart is recalling all batch codes and all use-by dates for the following products, which were distributed nationwide online and in stores:
ByHeart Whole Nutrition Infant Formula, 24 oz can (UPC 5004496800)
ByHeart Whole Nutrition Infant Formula Anywhere Pack™, 0.60 oz packets, 14-count (UPC 5004496802)
Although the formula is manufactured only in the U.S., Canadian officials have also issued a safety notice because some Canadian consumers may have obtained the product through cross-border purchases.
What parents should do right now
Consumers who have any ByHeart formula at home should stop using it immediately. The FDA advises parents to:
Document the package information — Take a photo or write down the lot details from the bottom of the container.
Store the product safely — Set it aside, mark it clearly as DO NOT USE, and keep it available in case health officials request it for testing.
Monitor for symptoms — If an infant shows any signs consistent with botulism, seek emergency medical care right away.
Discard after 30 days — If no symptoms develop, the container can be thrown away after a month.
Parents can report illnesses or adverse events through the FDA’s MedWatch system or SmartHub portal. ByHeart says consumers with questions can contact the company’s support team at hello@byheart.com or call 1-833-429-4327, available 24/7.