A growing outbreak of infant botulism infections that has caused at least 15 infants across a dozen states to be hospitalized since August has prompted organic baby formula manufacturer ByHeart to recall all of its products nationwide.
All of the infants were sickened after they consumed formula from the company, according to state and federal officials.
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Parents and caregivers are “urged to stop using any ByHeart Whole Nutrition infant formula immediately,” including all lot numbers and all cans and single serving packets, the Centers for Disease Control (CDC) said Tuesday.
If parents or caregivers have fed their children ByHeart formula and have not seen symptoms, the CDC has advised them to store leftover ByHeart powdered formula to potentially be tested in the event that more children continue to develop botulism. If a month passes without any symptoms being observed, the agency said the leftover formula can be thrown away.
No deaths have so far been reported in the outbreak, which includes 15 suspected or confirmed infant botulism cases as of this week, according to officials. Other cases are pending.
Here’s what we know so far.
Why is the formula being recalled, and which products are included?
ByHeart issued a voluntary, nationwide recall of all of its products on Tuesday, after two additional instances of botulism infections were detected, making for 15 reported cases linked to their products.
The move expanded on ByHeart’s previous voluntary recall of two batches of its powdered baby formula announced on Saturday, after federal officials notified the company that 13 infants in 10 states who developed botulism infections had consumed ByHeart formula.
“The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point,” Mia Funt and Ron Belldegrun, co-Founders of ByHeart, said in a statement on Tuesday.
The 15 infants affected by the outbreak range in age from 16 days to around five months and fell ill between Aug. 9 and Nov. 10,, according to the Food and Drug Administration (FDA). All of them were hospitalized. .
ByHeart products are sold in major retail stores around the country including Target, Walmart, and Whole Foods. The ByHeart founders said that they began conducting tests on all ByHeart batches after learning about the outbreak on Friday. The company has partnered with the FDA for the recall expansion.
From Aug. 1 through Nov. 10, 84 infants nationwide have received treatment for botulism. Among them, 36 consumed powdered infant formula, and 40% of that group, totalling 15, consumed ByHeart Whole Nutrition infant formula, according to the FDA.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the FDA said in a statement.
The agency has not identified any other infant formula brands that pose similar risks. Investigations remain ongoing.
“We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do,” Funt and Belldegrun said.
What is infant botulism?
Infant botulism is a bacterial illness that disrupts the body’s nervous system and can be fatal if it goes untreated.
Infants with infant botulism can exhibit symptoms including respiratory difficulty, sluggish pupils, constipation, diminished reflexes, and weakened gag reflexes, among others.
A stool specimen is required for a definitive diagnosis, but the CDC advises that caregivers begin treatment immediately after a clinical consultation that supports an initial diagnosis and not wait for laboratory confirmation.
Suspected cases of infant botulism must be reported to state health departments, which then report confirmed cases to the CDC.
Which states have been impacted?
The states in which infants were hospitalized for botulism after consuming ByHeart formula include Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
It follows other major recalls in recent years
Several other formula companies have issued significant recalls in the past few years, at one point contributing to a severe nationwide shortage that left parents scouring stores for available formula..
Abbott Laboratories recalled three popular baby-formula products and closed a major factory in 2022, exacerbating shortage caused by supply chain disruptions and other pressures amid the COVID-19 pandemic.
During the ensuing period, 40% of popular baby formula brands were sold out at U.S. retailers, forcing stores like Walgreens and CVS to limit the amount of formula customers could buy.
The following year, in December 2023, Nutramigen Hypoallergenic Infant Formula Powder was recalled across the U.S. due to potential bacterial contaminations, marking the second recall from manufacturer Reckitt/Mead Johnson Nutrition in less than twelve months.
In that second instance, hundreds of thousands of cans of Nutramigen were recalled after the Israeli Ministry of Health informed the FDA that exported batches from the U.S. had tested positive for the Cronobacter bacteria, which can cause severe or even fatal infections in infants. The FDA claimed there was no reason for concern during the recall.
The federal government is the largest buyer of baby formula in the U.S., where about 40% of babies get formula through federal food assistance programs. The FDA said the current infant botulism outbreak “does not create shortage concerns of infant formula for parents and caregivers,” noting that ByHeart formula products account for less than 1% of infant formula sold in the U.S.
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