On November 8, Byheart Whole Nutrition voluntarily recalled two batches of infant formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism. On November 11, the FDA requested a recall expansion to include all ByHeart infant formula on the market. ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. Since then, the Camden County Health Department has worked diligently to ensure that all locations where the product is typically sold have cleared it from shelves.
As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states, including New Jersey.
“In response to this recall, our Registered Environmental Health Specialists conducted investigations at 17 retailers throughout Camden County that were identified as retailers of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs,” said Commissioner Virginia Betteridge, liaison to the Department of Health and Human Services. “We ensured that the products were removed from the shelves, and that retailers were notified of their obligations under the recall. We will continue to monitor the situation as it evolves.”
Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants.
The FDA advises parents and caregivers to stop using any ByHeart infant formula products immediately. If your child consumed ByHeart formula and is experiencing symptoms seek immediate medical attention. If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
If you still have the formula in your home, you should:
Take a photo or record the information on the bottom of the package.
Keep the container in a safe spot and be sure to label that product as DO NOT USE.
If your child develops symptoms, the state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
Affected infants can present with some or all of the following signs and symptoms:
Constipation
Poor feeding
Ptosis (drooping eyelid)
Sluggish pupils
Low muscle tone
Difficulty sucking and swallowing
Weak or altered cry
Generalized weakness
Respiratory difficulty
Possible respiratory arrest