ByHeart a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii. No distributed ByHeart product has tested positive for the bacteria.
The product being recalled is ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24 oz containers. 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 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.
It is important to note that this recall is not related to ByHeart’s own manufacturing in any way. In addition, the company has not received any consumer complaints that would indicate any illness, to date; illness complaints are an early detection of safety concerns. If a baby has already consumed all of the formula, there is no reason for concern, and no additional action is needed. If parents have any questions, they should consult with their pediatrician.
ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable 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, we are now recalling all product produced during the entire production run.
If your infant is experiencing symptoms related to Cronobacter infection, contact your health care 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.