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December 11, 2022 from the FDA.

ByHeart, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii. No distributed ByHeart product has tested positive for the bacteria.

The product being recalled is ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24 oz containers. The formula under voluntary recall was distributed directly to consumers in the U.S. and can be identified by the number on the bottom of the can. Recalled product batches are 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 printed with use by 01 JAN 24 or 01JUL 24.

ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable third-party packager. 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. Out of an abundance of caution, we are now recalling all product produced during the entire production run.

Customers who purchased ByHeart product should check the bottom of the can and dispose of product from batches 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1. ByHeart is setting up a webpage at https://byheart.com/noticesExternal Link Disclaimer with additional information about its measures. Should customers have any other questions or want to find out if the product they have is included in the voluntary recall, please email notices@byheart.com or text ByHeart at 1-909-506-2354. The company will also be reaching out directly to all customers via email who purchased orders from these identified batches.