On November 11, 2025, ByHeart voluntarily recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack™ sticks that were manufactured at its facilities in the United States. Specifically, the company expanded its initial recall from two batches to all products, regardless of expiration date. The reason for the recall is due to concerns of Clostridium botulinum contamination linked to reported cases of infant botulism in infants who have ingested these products.
Clostridium botulinum bacteria can cause infant botulism, a severe, life-threatening, and rare illness that affects the nervous system by producing toxins in the immature digestive tract of babies under 1 year old. Symptoms of this condition can include constipation, poor feeding, weak cry, drooping eyelids, sluggish pupils, flattened facial expression, diminished suck and gag reflexes, loss of head control, generalized weakness, and breathing difficulties. It may lead to progressive paralysis, respiratory failure, and the need for hospitalization. Infants under 6 months are at highest risk, and while treatable with antitoxin, delays can result in prolonged recovery or, in rare cases, death.
The FDA announced it is investigating consumer complaints of infant botulism infections in infants who ingested the formula. Specifically, the FDA is investigating complaints of 15 infant illnesses in the states of Arizona, California, Illinois, Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The affected formula was distributed throughout the United States. Our firm is investigating potential cases in both Missouri and Kansas, and across the country.
As a result of the 15 known infant botulism cases related to ByHeart products, the FDA is advising consumers not to use any ByHeart Whole Nutrition Infant Formula cans or Anywhere Pack™ sticks. The FDA and CDC have initiated an investigation into the outbreak, and preliminary lab results from one sample showed bacteria capable of producing botulinum toxin. In addition, ByHeart’s history includes a 2023 FDA warning for Cronobacter detection in a batch, raising concerns about ongoing quality controls. Again, as this is a product used as the sole source of nutrition for our newborns and infants, the FDA is obviously deeply concerned about these reports of bacterial infections.
Preuss | Foster Law is currently litigating a case against baby formula manufacturer, Abbott Laboratories, related to contaminated infant formula arising out of a recall in 2022. We have now been asked to investigate potential cases arising out of the ByHeart recall. If you believe that you or a loved one has been affected by ByHeart or other types of baby formula, please contact us immediately. We are passionate about these extremely scary and sad cases involving babies. We want to be there to help you and your family figure out what to do next if your child has been impacted by one of these formula products.