ByHeart, a baby formula manufacturer with a plant in the southern Iowa city of Allerton, has issued a nationwide voluntary recall of its products over concerns about cases of botulism in infants that have consumed it.
In a statement issued Tuesday, Nov. 11, on its website, the New York-based company said the move was being made to “ensure your baby’s safety.”
The company did not immediately respond to emails from the Des Moines Register.
The announcement extending the recall to all ByHeart products ― both canned formula powder and the company’s single-serve Anywhere Pack sticks ― follows an announcement Monday that it as recalling two specific lots of baby formula.
The U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention, along with state health departments, are investigating an outbreak of infant botulism in 10 states. There have been 13 cases documented in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, according to a Nov. 8 FDA statement.
The federal health agencies noted that all 13 cases in the outbreak, which began in August, were reported to have involved consumption of ByHeart powdered infant formula.
In its statement, ByHeart said, “Neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula.”
But ByHeart’s statement said the company decided to broaden the recall to all of its products after a call late Monday from the FDA notifying it that two more cases of botulism had been detected in babies that had consumed its formula, bringing the total to 15.
“The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions,” the company said.
In addition to conducting is own testing, ByHeart said it is providing health agencies with “complete and unrestricted access to all of our facilities and products for their investigation.”
The FDA said officials in several states have collected leftover infant formula for testing. Results are expected in coming weeks.
“At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision,” ByHeart said in its statement, adding that it is providing information on how to switch formula on its website, byheart.com.
Most infants with botulism initially will develop constipation, poor appetite, loss of head control and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest, according to the FDA. It said symptoms can take as long as several weeks to develop following formula ingestion.
ByHeart products represent less than 1% of all infant formula sold in the United States and the recall will not impact the national supply of baby formula, according to the FDA.
Founded in 2016, ByHeart has manufacturing facilities in Reading, Pennsylvania and Portland, Oregon, as well as Allerton. It purchased the Allerton facility from DairiConcepts, a subsidiary of Dairy Farmers of America, in January of 2023.
(This story was edited to add a photo.)
Kevin Baskins covers jobs and the economy for the Des Moines Register. Reach him at kbaskins@registermedia.com.
This article originally appeared on Des Moines Register: ByHeart issues nationwide baby formula recall due to concerns of potential botulism
Reporting by Kevin Baskins, Des Moines Register / Des Moines Register
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