UPDATE: As of Monday, Nov. 24, a total of 31 babies have been diagnosed with botulism related ByHeart hole Nutrition Infant Formula products, including two in Washington. News reports say that the recalled formula is still being found in some stores. If you see ByHeart products on store shelves, alert a store manager immediately.
The New York-based infant formula manufacturer ByHeart has recalled all its formula products following an outbreak of infant botulism. Parents and caregivers should immediately refrain from feeding any ByHeart products to infants or children.
As of today, health investigators are looking at 15 cases of the disease, including one in Washington state, which may be linked to the company’s product. The voluntary recall includes all ByHeart cans or single-serve Anywhere Pack™ sticks.
Don’t use any ByHeart formula products
“We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do,” wrote Mia Funt and Ron Belldegrun, co-founders of ByHeart. The company initially recalled two lots of formula on November 8 in response to concerns from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
In their November 11 statement, Funt and Belldegrun wrote: “The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority.”
The company has provided the FDA “complete and unrestricted access to all of our facilities and products for their investigation.” BytHeart is also conducting testing, the founders said, adding “neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula.”
What parents should know about the outbreak and recall
- What does the CDC warning say? According to a joint statement, the “CDC and FDA are concerned that other lots of ByHeart Whole Nutrition infant formula may be contaminated and are making infants sick with infant botulism.” The agencies urge parents and caregivers to stop using any ByHeart Whole Nutrition infant formula immediately.
- Where is ByHeart Whole Nutrition Infant Formula sold: Online and in major retailers nationwide.
- How many Washington infants have gotten sick? So far, only one local infant is linked to the recall.
- What you should do
If you have the recalled formula
- Do not use it or any ByHeart Whole Nutrition infant formula.
- If you have this formula, record the lot number and best-by date.
- If you have leftover ByHeart powdered formula that your infant was fed, keep it stored for at least a month. 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 away the leftover formula.
- Wash items and surfaces that may have come into contact with the formula using hot, soapy water or a dishwasher.
- If you see products for sale at a local business, inform them of the recall. Businesses should also wash items and surfaces that may have come in contact with the formula.
Symptoms
When should you seek immediate medical care for your infant? According to the CDC warning, “Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing. If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.”
If your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of the following symptoms, you should call your provider immediately:
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- Poor feeding
- Loss of head control
- Difficulty swallowing
- Decreased facial expression
Note: Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.
Treatment
The frontline treatment for infants with botulism is called BabyBIG® (Botulism Immune Globulin Intravenous (Human), or BIG-IV). It is the only FDA-approved medication for the treatment of infant botulism caused by toxin types A or B in patients younger than one year of age.
