ByHeart Infant Formula Recalled Due to Potential Contamination

Five lots of formula are being recalled after a sample tested positive for Cronobacter sakazakii, rare but serious bacteria

By Lisa L. Gill

Published December 15, 2022 | Updated December 16, 2022

Recalled By Heart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months — ByHeart recalled some of its Whole Nutrition Infant Formula because of possible contamination with dangerous bacteria.

Update: This story has been updated to reflect that per the Food and Drug Administration, the ByHeart recall affected 30,000 cans (not 30,000 people.)

The company ByHeart has recalled five lots of infant formula because they could be contaminated with Cronobacter sakazakii, rare but serious and sometimes deadly bacteria. No illnesses have been reported.

The product being recalled is called ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months. It’s packaged in 24-ounce containers that will have one of these codes on the bottom of the can: 22273 C1, 22276 C1, 22277 C1, 22278 C1, or 22280 C1, and a use-by date of “01 JAN 24” or “01JUL 24.”

The company told CR in a statement that Cronobacter was detected in a sample collected from a third-party facility that packages the formula for ByHeart. All products packaged on that day, and from the first production on the next day, were destroyed and were not distributed, the company said.

“No distributed ByHeart product has tested positive for the bacteria, but out of an abundance of caution, the company is recalling all products produced during the entire production run,” a company spokesperson said.

Cronobacter bacteria can easily contaminate surfaces at a production facility, says James E. Rogers, PhD, director of food safety and testing at Consumer Reports. And it can survive in powders, including powdered formula, sometimes for months.

ByHeart is a relatively new subscription-based infant formula company with a production facility in Reading, Pa.

A spokesperson for the Food and Drug Administration told CR that the recalled products were not sold in retail stores, and about 30,000 cans were sold through the company’s website to customers.

The recall comes on the heels of a series of large infant formula recalls announced earlier this year by Abbott Labs that led to a nationwide, months-long formula shortage that left many store shelves empty and parents scrambling. Follow-up investigations by CR and others found delays in the FDA’s response, which recently led to the agency calling for a review of its programs that regulate food.

The FDA told CR that ByHeart’s recall was relatively small and “will not have a significant impact on the broader availability of infant formula in the U.S., where production continues to exceed demand.” It added that because the ByHeart formula isn’t part of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program, there’s no impact on WIC customers.

Risk of Cronobacter

Cronobacter is a relatively rare infection, according to the Centers for Disease Control and Prevention. At greatest risk are infants 2 months or younger and those who may have weakened immune systems from being sick with other conditions or receiving medical treatment.

Symptoms include fever, poor feeding, crying, or very low energy, according to the Centers for Disease Control and Prevention. In more advanced cases, the bacteria can cause a blood infection and sepsis, as well as swelling around the linings of the brain and spinal cord, also known as meningitis.

Showing where the expiration date and batch number are on the recalled By Heart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months — Check the bottom of your ByHeart Infant Formula can for the recalled lot code, or batch, number.

The Details

Products recalled: ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24-ounce containers that are marked on the bottom with one of these numbers: 22273 C1, 22276 C1, 22277 C1, 22278 C1, or 22280 C1, marked with use-by dates of 01 JAN 24 or 01JUL 24.

The problem: The infant formula may be contaminated with Cronobacter.

The fix: Throw it out. Customers who purchased the recalled formula should receive an email from ByHeart saying it will offer two additional cans of formula in coming shipments.

How to contact the manufacturer: Consumers with questions can email the company at notices@byheart.com or send a text to 909-506-2354. The company has also published an FAQ about the recall.

Correction: This article, which originally published on Dec. 15, 2022, should have said that about 30,000 cans had been distributed to customers.

Lisa L. Gill

As a dorky kid, I spent many a Saturday at the Bloomington, Ind., public library, scouring Consumer Reports back issues for great deals. Now, as a (much) bigger kid, that's still my job! Identifying products and services, especially in healthcare, that are safe, effective, and affordable—and highlighting those that aren't—is my top concern. Got a tip? Follow me on Twitter ( @Lisa_L_Gill)