Beware of this baby formula: FDA issues recall warning as infant botulism outbreak spreads to 12 states

ByHeart Whole Nutrition Infant Formula is being recalled in 12 states due to 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.

As of November 10, 15 infants who were either fed the formula or exposed to it have developed infant botulism in 12 different states. Those states are: Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The investigation remains ongoing.

All 15 infants were hospitalized, and no deaths have been reported. Information is available for 14 of those cases, with the illnesses occurring between August 9 and 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 the company hasn’t found the “toxins in any unopened can of ByHeart formula,” it “decided to voluntarily recall all ByHeart formula nationwide” including unexpired lots of formula cans and single-serve “anywhere” sticks.

ByHeart infant formula products make 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

Botulism can be fatal, and the FDA recommends taking action right away. According to the agency, parents and caregivers should stop using any ByHeart infant formula products immediately.

If you suspect a child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and 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, the agency recommends you to 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.

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