ByHeart, a newcomer baby nutrition brand that is only available online, said it is voluntarily recalling five batches of its infant formula over concerns of bacterial cross-contamination.
A test sample from a third-party company that cans ByHeart's formula tested positive for Cronobacter sakazakii, ByHeart said in a Sunday notice posted to the FDA's website. The germ can cause rare but deadly illness in infants, leading to blood infections and other serious complications.
ByHeart says none of its distributed products tested positive for the bacteria, and it had not received any customer complaints of illness.
"All product packaged that day, and the first production on the next day, was isolated for destruction and not distributed," the notice said. "Out of an abundance of caution, we are now recalling all product produced during the entire production run."
The company said in an FAQ that it conducts daily testing during formula production and tests cans throughout the day: "We are confident in our rigorous testing program."
What products were recalled?
ByHeart is recalling five batches of its Whole Nutrition Infant Formula: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1. Batch numbers and expiration dates are printed on the bottom of the cans. Responding to an emailed inquiry, the company did not say how many cans are included in the recall.
ByHeart's formula is only sold online through its website; the product isn't available in grocery stores. A September 2022 Forbes review says customers can purchase 24-ounce cans a la carte for $39 or sign up for a subscription plan.
The company said in the FAQ that it is refunding all customers who received affected batches, and that the fastest way to get a refund is to have the cost of two alternative formula cans covered. According to the notice, affected customers "will receive two cans of their next order of ByHeart Whole Nutrition Formula for free."
The company encouraged anyone whose infant is showing symptoms of a Chronobacter infection to contact their health provider for immediate care.
The February shutdown of the Abbott Nutrition factory that caused a huge recall and nationwide supply shortage this year followed infections of Chronobacter as well as salmonella.
According to Forbes, ByHeart was founded in 2016 and only carries one type of formula. The company announced in April 2022 that its Pennsylvania manufacturing facility was registered with the FDA.