11/11/2025
Recalled infant formula
CDC and FDA are concerned that other lots of ByHeart Whole Nutrition infant formula may be contaminated and are making infants sick with infant botulism. Parents and caregivers have reported feeding infants in this outbreak different lots of ByHeart infant formula that were not included in the company's recall on November 8, 2025. On November 11, 2025, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products.
Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes:
All lot numbers
All sizes of cans and single serve packets
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
What you should do
Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
If possible, record the lot number and best by date.
If you have leftover ByHeart powdered formula that your infant was fed, keep it stored for at least a month. If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
Poor feeding
Loss of head control
Difficulty swallowing
Decreased facial expression
Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.
