ByHeart is recalling five batches of ByHeart Whole Nutrition Infant Formula because of the potential for cross-contamination with Cronobacter sakazakii. 

ByHeart is taking this measure because one test sample collected from the third-party packaging facility tested positive for Cronobacter sakazakii. All product packaged that day, and the first production on the next day was isolated for destruction and not distributed.

The company says that no distributed ByHeart product has tested positive for the bacteria. The production plant runs 24 hours a day, seven days a week.

The formula under voluntary recall was distributed directly to consumers in the U.S. and can be identified by the number on the bottom of the can. 

Recalled product:

• The product being recalled is ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24 oz containers. 
• Recalled product batches are 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 printed with use by 01 JAN 24 or 01JUL 24.

As of the posting of this recall, no consumer complaints have been received that would indicate any illness.

According to the company announcement, the recall is not related to ByHeart’s own manufacturing facility in Reading, PA in any way. The facility continues to run 24 hours a day, seven days a week, and re-stock is expected in January.

What customers should do
Customers who purchased ByHeart products should check the bottom of the can and dispose of products from batches 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1. ByHeart has set up a webpage at https://byheart.com/notices with additional information about its measures. 

If your infant is experiencing symptoms related to Cronobacter infection, contact your healthcare provider to report their symptoms and receive immediate care. To report an illness or adverse event, you can

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

About Cronobacter
Food contaminated with Cronobacter may not look or smell spoiled but can still cause illness. Although Cronobacter Is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns. The severe cases often lead to death.

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