A Pennsylvania-based infant formula manufacturer is recalling 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. The bacteria can cause severe, life-threatening infections such as sepsis or meningitis.
The product being recalled is ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24 oz containers. It was distributed directly to consumers across the U.S.
Recalled product batches are 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 printed with use by 01 JAN 24 or 01 JUL 24. The information is located on the bottom of the container.
The FDA has received no reports of consumer complaints that would indicate any illness, to date.
"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," the FDA said.
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.
The recall is not related to ByHeart’s own manufacturing in any way, the FDA said. ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a third-party packager.
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. No distributed ByHeart product has tested positive for the bacteria.
ByHeart's facility in Reading, PA continues to run 24/7. A re-stock is expected in January.
In a statement, ByHeart said it will be reaching out directly to all customers via email who recently purchased orders. The company is offering to cover the cost of two cans of formula, plus affected customers will receive two cans of their next order of ByHeart Whole Nutrition Formula for free.
"The safety of your family is our number one priority... We know that the most important thing we can do is be transparent with you and over-communicate and we will continue to do just that," the company said. "Parents can remain confident in the safety of ByHeart’s products as we continue to expand our investments in infant formula innovation, clinical studies, and industry-leading quality standards."
Consumers with questions can contact ByHeart by email at notices@byheart.com or text 1-909-506-2354.
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