- At least 15 infants were hospitalized with botulism after consuming ByHeart formula.
- The FDA has recalled all ByHeart formula products amid ongoing investigations.
- Symptoms of infant botulism can take weeks to appear and require vigilance from parents.
Parents nationwide are being cautioned not to feed their infants any ByHeart Whole Nutrition formula. ByHeart Inc. is recalling all of the product after at least 15 infants in multiple states have been hospitalized with botulism after drinking the baby formula. More cases are pending.
The recall, announced by the U.S. Food and Drug Administration, includes all sizes of cans and Anywhere Pack single-serve sticks. The formula is sold online and at major retailers nationwide. The chief medical officer for ByHeart Inc., Dr. Devon Kuehn, told the Associated Press that the company sells about 200,000 cans of infant formula a month online and in stores including Target, Walmart, Albertsons and Whole Foods.
Tuesday, the FDA reported that since Aug. 1, “84 infants nationwide have received treatment for infant botulism.” Of those, at least 15 consumed the ByHeart powdered infant formula prior to developing symptoms.
The ByHeart brand makes up a very small share of U.S. infant formula sales, the advisory reported. So it’s not likely to create shortage concerns.
However, “This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.”
The initial recall has been expanded, per FDA, “to include all ByHeart infant formula products due to the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program."
What is infant botulism?
Infant botulism is an often slow-developing and potentially life-threatening illness that usually appears as constipation, poor feeding, loss of head control and difficulty swallowing, per the Centers for Disease Control and Prevention. It happens when a baby ingests Clostridium botulinum spores, which can germinate in the infant’s digestive tract and produce botulinum toxin.
Symptoms include:
- Poor feeding
- Loss of head control
- Difficulty swallowing
- Decreased facial expression
- Pupils that are slow to react to light
- Low muscle tone
- Weaker cry
- Drooping eyelids
It is a medical emergency. Botulism can be fatal. “Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms,” the CDC warns.
States with confirmed cases of infant botulism include Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
Now what?
Parents and other caregivers are warned to stop feeding that ByHeart formula immediately, symptoms or not.
Even without symptoms, the formula should be kept for 30 days. Mark it DO NOT USE and put it in a safe place. An advisory from CDC says parents should record the lot number and best by date. “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.”
Other advice from the CDC related to the recall includes washing any surfaces or items the formula might have touched, using hot soapy water or a dishwasher and seeking immediate care if an infant was fed any of the product and develops symptoms.
The announcement notes that it takes as long as several weeks for the infant botulism symptoms to appear, so parents “should remain vigilant” if they used that brand of formula.