Per the U.S. Food & Drug Administration,, 13 children have been hospitalized since August after consuming ByHeart Whole Nutrition Infant Formula. Texans should be on the lookout for an organic baby formula that is being recalled by federal officials.
10 states including Texas have been linked for cases of infant botulism from the baby formula product. No deaths were reported.
In a statement, ByHeart, a company based in New York City, said it was informed on Nov. 7 that the FDA had identified about 83 cases of infant botulism nationwide since August, with 13 involving babies who had consumed its formula. The company added that both government and internal testing had so far found no traces of botulism in its product.
"ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants," the company said. "The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism."
Here's what ByHeart baby formula products are being pulled along with lot code and "Use by" date:
- Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
- Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
Per the U.S. Centers for Disease Control and Prevention, Infant botulism is a rare but serious illness that affects babies, typically under one year old. It occurs when Clostridium botulinum spores—found naturally in soil, dust, and sometimes foods like honey—enter an infant’s intestines and begin to grow. These bacteria produce a toxin that interferes with nerve function, leading to muscle weakness and paralysis.
Here's signs that an infant has signs of the illness:
- The spores of C. botulinum germinate and release botulinum toxin in the baby’s gut.
- Constipation is often the first sign, followed by poor feeding, weak cry, drooping eyelids, lethargy, and muscle weakness. Severe cases can cause breathing difficulties.
- Unlike foodborne botulism in adults, infant botulism results from the bacteria colonizing the intestine rather than ingesting preformed toxin.
- It’s typically treated in hospitals with Botulism Immune Globulin.
The FDA and CDC, working together with the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) and other state and local partners, are investigating a multistate outbreak involving 13 cases of infant botulism reported across 10 states.
Here are the states and how many cases were reported:
- Arizona: 1 case
- California: 2 cases
- Illinois: 2 cases
- Minnesota: 2 cases
- New Jersey: 1 case
- Oregon: 1 case
- Pennsylvania: 1 case
- Rhode Island: 1 case
- Texas: 2 cases
- Washington: 1 case
The FDA advised parents and caregivers who have the product to note the identifying details printed on the bottom of the package and dispose of it immediately. The agency added that it is coordinating with retailers to remove "all potentially affected products" from store shelves.