The FDA is advising consumers that Byheart is recalling five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii.
The product being recalled is ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24 oz containers (see image of label attached). The formula under recall was distributed directly to consumers and can be identified by the number on the bottom of the can. 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.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is done by a third-party packager. ByHeart is taking this precautionary 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. Out of an abundance of caution, this recall is happening for all product produced during the entire production run.
To date, Byheart has not received any consumer complaints that would indicate any illnesses. (Illness complaints are an early detection of safety concerns.)
Customers who purchased ByHeart product should check the bottom of the can and dispose of product from batches 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1. ByHeart is setting up a webpage at https://byheart.com/notices with additional information about its measures. Should customers have any other questions or want to find out if the product they have is included in the voluntary recall, they should email notices@byheart.com or text ByHeart at 1-909-506-2354. The company will also be reaching out directly to all customers via email who purchased orders from these identified batches.
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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