ByHeart Whole Nutrition Infant Formula is being recalled in 12 states due t o concerns it may be contaminated with Clostridium botulinum, as the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention continue to investigate a multi-state outbreak of infant botulism, along with local and state partners.
As of November 10, 15 infants who were either fed the formula, or exposed to it, have developed infant botulism in 12 different states. The investigation remains ongoing. Those states are: Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
All 15 infants were hospitalized, and no deaths have been reported. Information is available for 14 of those cases, with the illness occurring between August 9 to November 10. Those 14 infants range in age from 16 to 157 days old.
ByHeart released a public statement on November 11 which said that while they haven’t found the “toxins in any unopened can of ByHeart formula” nonetheless they “decided to voluntarily recall all ByHeart formula nationwide” including unexpired lots of formula cans, and single-serve “anywhere” sticks. (ByHeart infant formula products makes up less than 1% of all infant formula sold in the U.S.)
Infant botulism symptoms
According to the FDA, most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.
FDA recommendations
Parents and caregivers should stop using any ByHeart infant formula products immediately. If you suspect a child has consumed ByHeart formula, and is experiencing symptoms, seek immediate medical attention.
If a 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 a child develops symptoms, your state health department might want to collect your formula container for testing. If a child does not develop symptoms after 30 days, throw your containers out.
Botulism can be fatal, and the FDA recommends taking action right away. If a child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms, seek immediate medical attention.