Baby formula linked to botulism outbreak still on some shelves, FDA warns
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ByHeart is recalling all of its infant formula products after they were linked to a botulism outbreak in several states. Photo By Al Drago/CQ Roll Call
Infant formula linked to a growing botulism outbreak may still be on shelves in several states, the FDA said this week.
The big picture: There were at least 31 infants with suspected or confirmed infant botulism linked to ByHeart brand formula as of Wednesday, the FDA said, but even after announcing a recall, the formula was still being sold across the country.
Driving the news: ByHeart Whole Nutrition Infant Formula recalled all of its products earlier this month, but the FDA said on Thursday that some cans of the formula were still at Walmart, Target, and Kroger stores.
What we're watching: The parents of at least two children have sued the makers of the ByHeart baby formula.
What they're saying: "As part of our safety standards, and in alignment with regulatory requirements, we have notified all retail partners to remove all ByHeart formula from their shelves," ByHeart told Axios in a statement.
- "Since November 9, ByHeart has notified retailer partners four times, and they have confirmed communication has been sent to stores. The FDA has also shared notifications with individual retailers."
- "Additionally, based on Consumer Product Recall Best Practices, there are safeguards in place to ensure that purchases of ByHeart infant formula cannot be completed if product is still on shelves and is scanned at check out systems."
Here's what to know:
Where ByHeart-linked botulism has been reported
State of play: As of Wednesday, 31 infants with suspected or confirmed infant botulism who had confirmed exposure to ByHeart Whole Nutrition infant formula were reported from 15 states, according to the FDA.
- Those states are: Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
Catch up quick: The outbreak has grown rapidly since the FDA first announced its investigation earlier this month.
- On Nov. 8, the agency said that out of an estimated 83 cases of infant botulism reported since August, only 13 children had consumed ByHeart formula at some point.
- The outbreak is unusual, given that botulism is uncommon in dairy products and "there is no historical precedent of infant formula causing infant botulism," the FDA said at the time.
Affected products
The recall includes all batch codes and use by dates for the following products:
- ByHeart Whole Nutrition Infant Formula, 24 oz can, UPC: 5004496800
- ByHeart Whole Nutrition Infant Formula, 0.60 oz Anywhere Pack, 14 packets per package, UPC: 5004496802
What to know about infant botulism
Zoom out: Infant botulism is "a rare, life-threatening condition that can cause a slow form of paralysis in infants," according to Cleveland Clinic.
- "Unlike botulism in older children and adults, infant botulism can come on slowly and get gradually worse over time."
Zoom in: Infant botulism often begins with constipation but is "usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control," according to the CDC.
What to know about ByHeart
ByHeart is one of several new entrants shaking up the infant nutrition industry, which is historically controlled by a handful of manufacturers.
- It currently holds about 1% of U.S. formula sales.
- Founded in 2016, the company was the first new company to register with the FDA in 15 years.
The company has capitalized on the Trump administration's "Make America Healthy Again" push, branding its products as organic and nature-based.
- Health and Human Services Secretary Robert F. Kennedy Jr. has scrutinized baby formula for ingredients such as seed oils, which are decried by many wellness influencers.
- Ron Belldegrun, one of the company's co-founders, published an op-ed in June that said "reducing the need for added oils like soy or palm" was among the benefits of using whole milk instead of skim.
Editor's note: This story has been updated with a statement from ByHeart.
