Possible contamination at third-party packager leads to recall of ByHeart baby formula

Manufacturer ByHeart is recalling and destroying five batches of its milk-based powder with iron baby formula due to possible bacterial contamination, the company announced through the Food and Drug Administration Sunday.

Specifically, five batches of 24-ounce ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months formula have been recalled. The formula was distributed directly to consumers and can be identified by numbers on the bottom of the can.

The recalled batches are “22273 C1, 22276 C1, 22277 C1, 22278 C1 and 22280 C1 printed with use by Jan. 1, 2024, or July 1, 2024,” according to the FDA’s notice. 

The batches being recalled have a possibility of cross-contamination with the bacterium Cronobacter sakazakii, which can cause sepsis, meningitis and bowel damage. 

Thus far, no distributed ByHeart formula has tested positive for Cronobacter sakazakii, nor have any consumer complaints of sickness been reported. 

“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 company told consumers.

Furthermore, the issue does not stem from ByHeart’s manufacturing, which is company-owned except for the packaging. ByHeart is headquartered in New York City.

“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,” the company explained.

Out of an abundance of caution, the entire production run for the formula has been recalled for destruction.

ByHeart is reaching out to customers who purchased formula from the recalled batches and is offering to “cover the cost of two cans of alternate formula,” according to the FDA announcement. Affected customers will also get two cans free in their next order.

“We are accountable to you — and part of accountability is to always try to do the right thing,” ByHeart founders Mia Funt and Ron Belldegrun wrote in a note to consumers on the company’s website, further urging that “the safety of your family is our number one priority — and we are here for you and with you. As you know, we’re ByHeart customers, too.”