Infant Formula Recall: Product Pulled Over Potential Cross-Contamination Risk

A company is voluntarily recalling some batches of its infant formula product because of possible cross-contamination with Cronobacter sakazakii bacteria.

ByHeart has issued the recall "out of an abundance of caution," the U.S. Food and Drug Administration (FDA) announced. None of the distributed products has tested positive for the bacteria. However "one test sample" from its third-party packaging facility tested positive for Cronobacter sakazakii.

"ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable third-party packager," the company explained. "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 products produced during the entire production run."

The company stressed the recall "isn't related to ByHeart's own manufacturing in any way."

Cronobacter sakazakii is a germ that lives in "very dry" environments," according to the U.S. Centers for Disease Control and Prevention (CDC). It can cause "severe, life-threatening" infections or meningitis.

The bacterial infection can be "very serious" and sometimes fatal for babies. It can also cause serious illnesses in the elderly and those who have "trouble fighting germs."

There have been no customer complaints regarding the recalled product.

The recall affects five batches of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months: Batch 22273 C1, 22276 C1, 22277 C1, 22278 C1 and 22280 C1. They were sold in 24-oz containers, with the use-by dates of either "01 JAN 24" or "01JUL 24." Photos of the product are available on the FDA website.

"No other batches are affected by this," the company noted. "All other batches from ByHeart are safe to continue to feed to your baby."

Customers who still have the product are advised to dispose of it. No action is needed if your babies have already finished the formula as "there is no reason for concern."

People whose babies are experiencing Cronobacter infection-related symptoms should contact their healthcare provider.

"While ByHeart works 24/7 to meet the demand for formula, the fastest way the company can replace the formula customers purchased is to cover the cost of two cans of alternate formula," the company added. "Additionally, affected customers will receive two cans of their next order of ByHeart Whole Nutrition Formula for free."

Those who have questions about the recall can text the company at 1-909-506-2354 or contact them through email at notices@byheart.com.

"We are accountable to you—and part of accountability is to always try to do the right thing," ByHeart said in a statement. "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."