ByHeart Formula Recalled Over Life-Threatening Cross Contamination Fears

When baby formula was invented in 1865, it was considered "the perfect infant food" according to a 2009 paper published in the Journal of Perinatal Education. In the century and a half since, science has come around to recognizing breast milk as a better option, per Hopkins Medicine. But not everyone can breastfeed, nor is nursing practical in all cases. So, for some families, baby formula offers the sole option for sustaining their infants (via Time). Accordingly, the baby formula shortage, which has been blamed, in part, on corporate greed, may have been brewing for some time even before February 2022, per NPR. That's when a major baby formula recall by Abbott Laboratories brought the issue to a head.

According to DrugWatch, Abbott initiated the recall after several infants were sickened by Cronobacter sakazakii (and one with Salmonella Newport) after consuming Abbott-manufactured formula, resulting in as many as five hospitalizations and two deaths, the FDA reported in February. Although efforts to ameliorate the shortage have been underway for some time, as recently as last week, we reported that the baby formula shortage may continue into 2023, due to continuing high demand combined with ongoing supply chain chaos, per Reuters.

Nor does it help that ByHeart has now recalled five batches of its Whole Nutrition Infant Formula, according to an FDA bulletin issued this week. Nor does it inspire consumer confidence that this recall was prompted — once again — by concerns of cross-contamination with potentially life-threatening Cronobacter sakazakii.

What you need to know about the recalled formula

On December 11, 2022, baby formula manufacturer ByHeart recalled what it describes as "five batches" of its Whole Nutrition Infant Formula, according to its website, and as reported by the FDA. The reason is "an abundance of caution" over concern the affected batches were exposed to potential cross-contamination with Cronobacter sakazakii. The bacteria was detected at ByHeart's packaging facility, which is owned and run by a third party.

Cronobacter sakazakii, which has also been referred to as Enterobacter sakazakii, may cause serious infection in some populations, including babies, according to the CDC. These infections, including sepsis and meningitis, are associated with jaundice, irritability, labored breathing, and failure to thrive, the FDA notes. In some cases, they may also result in organ damage, including to the intestines (per a 2008 study in The Journal of Infectious Diseases).

Fortunately, at this time, no infections have been reported by consumers, and none of the formula products actually sold by ByHeart have tested positive for any illness vector. Further, ByHeart notes that the issue did not arise during ByHeart's manufacturing of the product, but only during packaging. All affected product still in the company's possession has been isolated and destroyed. Only the remaining affected product is subject to this current recall. 

What to do if you have the recalled product

ByHeart's recalled baby formula comprises 24-ounce containers of milk-based powder with iron, intended for babies between the ages of zero and 12 Months, per the FDA. The affected batches were distributed directly to consumers, nationwide, and may be identified by one of the following batch numbers: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1. In each case, that information would be printed on the bottom of the can along with a use-by date of "01 JAN 24" or "01 JUL 24." Any such product should be destroyed and consumed by no one. 

ByHeart is planning to reach out to affected customers whose email addresses it has on hand, and it's agreed to provide two free cans to each affected customer. You can reach ByHeart directly at 1-909-506-2354. In the meantime, ByHeart reiterates that the contamination occurred at a third-party packaging facility; ByHeart's manufacturing facility continues to operate, uninterrupted, with no known contamination or other issues. The company currently expects to complete all necessary restocking during January 2023. 

Although there have been no reports of illness relating to ByHeart's recalled baby formula, it's nevertheless important to recognize the symptoms of infection with Cronobacter sakazakii. The CDC says the infection usually presents with "fever and poor feeding, excessive crying, or very low energy," and possibly, seizures. If you notice these or other symptoms in your baby, do not delay in contacting your healthcare provider.