Story at a glance
- The recall was initiated after a sample conducted by a third-party packager tested positive for Cronobacter sakazakii.
- However, no product distributed by ByHeart has tested positive for the bacteria.
- This bacteria can cause severe, life-threatening infections such as sepsis or meningitis.
READING, Pa. (WXIN) – An infant formula manufacturer is recalling an entire run of its product due to the possibility of cross-contamination with dangerous bacteria.
The U.S. Food and Drug Administration said the recall involves ByHeart’s Whole Nutrition Infant Formula. The recall was initiated after a sample conducted by a third-party packager tested positive for Cronobacter sakazakii. However, no product distributed by ByHeart has tested positive for the bacteria.
This bacteria can cause severe, life-threatening infections such as sepsis or meningitis. Meningitis is an inflammation of the membranes that protect the brain and spine.
The FDA says symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, and abnormal movements. The infection may also cause bowel damage and spread through the blood to other body parts.
“It is important to note that this voluntary recall is not related to our own manufacturing in any way, and we remain confident in our safety testing and quality program,” reads a statement from ByHeart. “We own our entire manufacturing supply chain, with the exception of final canning, which is conducted by a reputable third-party packager.”
After learning about the positive sample, ByHeart isolated all products packaged that day, and the first production of the next day. The company said out of an abundance of caution, it is now recalling all products produced during the entire production run.
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.
So far, the company has not heard from anyone indicating any illness. The FDA said if a baby has already consumed all the formula, there is no reason for concern. However, if parents are concerned, they should consult their pediatrician.
Anyone with the recalled formula should throw it away and contact ByHeart. They can email the company at notices@byheart.com or text it at 1-909-506-2354. The company will also reach out directly to all customers who purchased orders from these identified batches via email.
“In the meantime, our priority is to make sure that all customers have what they need to keep their babies fed and healthy, no matter what brand of formula they use,” reads a statement from ByHeart. “While we work diligently to meet the demand for formula, the fastest way we can replace the formula that you purchased is to cover the cost of two cans of alternate formula. Additionally, affected customers will receive two cans of their next order of ByHeart Whole Nutrition Formula for free. We will also be reaching out directly to all customers via email who recently purchased orders from ByHeart.”
Anyone whose infant is experiencing symptoms related to Cronobacter infection is urged to contact their 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 they wish to speak directly to a person about their problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.