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You may have seen on the news that ByHeart Whole Nutrition Infant Formula products have been voluntarily recalled by the manufacturer.  

It can feel confusing or upsetting to learn about a product recall, especially if your child has used it.  

CHOP team members have reviewed the information about this recall and here are some things to know. 

The CDC and FDA are investigating if this formula might be causing an illness called infant botulism. This is a serious illness, but it is rare.

Almost all infants feeding with ByHeart Whole Nutrition Infant Formula will be fine and will not get infant botulism. Nationwide, 15 infants have been diagnosed with infant botulism while using ByHeart formula. Even though this number is small, it is important that you take immediate action and stop using it. 

What to do if you use ByHeart Whole Nutrition Infant Formula 

• If you still have the product, take a picture of the lot number (found on the bottom of the can, or the back of a single serve package).
• Throw away any unopened ByHeart Whole Nutrition Infant Formula in the trash.
• If you have a supply of formula that was fed to your infant, consider keeping it safely stored inside a plastic bag or container, clearly marked "do not use," for up to one month for potential testing.
  • DO NOT feed this to your infant. This supply may be tested in the event your infant may develop symptoms consistent with infant botulism.
  • If your child does not develop any symptoms within one month, discard of unused formula.
• Wash all countertops and utensils that could have come in contact with the product with hot soapy water. 

Be reassured that the likelihood of getting sick after using the formula is very small. There is not a readily useful test for this form of botulism. No tests are recommended for healthy babies.  

No matter what formula your baby takes, if you have concerns that your baby is weak, or having trouble feeding, call your healthcare provider. If your baby drank recalled formula, be sure to tell them that, too.  

Why was this formula recalled?  

It was observed that 15 out of the 83 infants investigated for infant botulism this summer / fall had been using this formula. Statistically, this seems unusual, and it’s more patients than is expected. (So far, one opened can of the formula has been found to have botulism spores – testing of unopened cans has been negative, but is ongoing.)

More resources for your family  

Product concerns: You can contact the company at hello@byheart.com. If you would also like to report the exposure to someone else, you can also contact the  FDA Consumer Complaint Coordinator. 

Botulism concerns: The Poison Control Center at CHOP is staffed by nurses and pharmacists who offer expert information about poisons, like botulism.  You can call them free and 24/7 if you have additional questions about botulism at 1 (800) 222-1222. If you live outside of the state of eastern Pennsylvania or Delaware, you will reach your state’s Poison Center via that same number.   

Learn more: If you’d like to learn more about this recall, visit the CDC or FDA websites.

This information will be updated as we learn more.