Jessy Edwards  |  December 15, 2022

Category: Legal News

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Product photo of recalled infant formula by Byheart.
(Photo Credit: U.S. Food & Drug Administration)

Byheart infant formula recall overview: 

  • Who: ByHeart has recalled some of its Whole Nutrition Infant Formula. 
  • Why: The product has the potential for cross-contamination with Cronobacter sakazakii.
  • Where: The ByHeart infant formula recall is active in the United States.

ByHeart has recalled five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii. 

The voluntary recall notice was published Dec. 11 on the U.S. Food & Drug Administration website, and applies to ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24-ounce containers. 

The formula under recall 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 01 JUL 24.

The recall has been initiated out of an abundance of caution, and none of the distributed ByHeart product has tested positive for the bacteria, the company said. There have been no consumer complaints of illness to date, ByHeart said.

Formula recalled after contamination at canning factory

ByHeart said the potential contamination happened at the final canning stage, which is done 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,” it said.

ByHeart said 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.”

Cronobacter bacteria can cause severe, life-threatening infections or meningitis. If a baby has already consumed all of the formula, there is no reason for concern and no additional action is needed, the company said.

Customers should dispose of cans of the affected formula. The company said it will replace the missed formula by covering the cost of two cans of alternate formula. Additionally, affected customers will receive two cans of their next order of ByHeart Whole Nutrition Formula for free, it said.

In October, Abbott recalled certain lots of ready-to-feed liquid products for infants and children sold under various brands including Similac and Pedialyte, as some of the bottles may not be sealed properly.

If your premature or preterm baby was given Similac or Enfamil formula while in the NICU and developed necrotizing enterocolitis, you may qualify to join a free NEC baby formula class action lawsuit investigation.


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