Dec. 16, 2025:
UNDATED-AP- Four of the nation’s top retail stores failed to promptly pull contaminated infant formula tied to a dangerous botulism outbreak from their shelves, federal health officials said in warning letters posted Monday (Dec. 15, 2025).
The U.S. Food and Drug Administration sent letters to leaders at Walmart, Target, Kroger and Albertsons, saying the companies continued to sell ByHeart infant formula for days or weeks, despite a Nov. 11, 2025, recall of all products in the outbreak that has sickened more than 50 babies in 19 states.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12 and posted online Monday.
The formula was found at Target stores in 20 states “well after the recall was initiated,” one letter said. In addition, it was sold at a Target store in New Hampshire on Nov. 16, despite an electronic block on the product’s sales code, the FDA noted. And at a Target store in Arkansas, single-serve packs of ByHeart formula were promoted with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
Information from state and local health officials said ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26. The formula was found in Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19.
In addition, the companies failed to provide FDA with evidence that corrective actions have been put in place, despite multiple requests, the agency said. The companies have 15 working days to respond to the letters.
Walmart officials said in a statement that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall.
“We moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online,” a company spokesperson said in an email. “We take all reports of inaction seriously and will respond to the letter.”
Albertsons officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.
“ByHeart infant formula products have been removed from our store shelves,” the company said in a statement.
All of the babies in the outbreak have been hospitalized and treated with an IV medication to stop the progress of the disease. The U.S. Centers for Disease Control and Prevention expanded the outbreak to include all babies treated for botulism after consuming ByHeart formula since it was first produced in 2023.
Steven Mandernach, executive director at the Association of Food and Drug Officials, said the FDA itself was slow to distribute information about the recall with state and local food safety officials. The agency didn’t fully share product lists until Nov. 14 — nearly a week after the initial recall of two lots of ByHeart formula on Nov. 8.
He said it was “disappointing” in an outbreak involving the sole source of nutrition for vulnerable infants.
“There probably wasn’t the sense of urgency to ensure the product was off the market that I would expect,” Mandernach said.
Dec. 11, 2025:
UNDATED-AP- Federal health officials on Wednesday (Dec. 10, 2025) expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.
No deaths have been reported in the outbreak, which was announced Nov. 8.
Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. Another 12 cases were identified with the expanded definition, including two that occurred in the original timeline and 10 that occurred from December 2023 through July 2025.
ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.
News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo, 36, of Redondo Beach, California, said she insisted on using ByHeart formula to supplement a low supply of breast milk because it was recommended by a lactation consultant as “very natural, very gentle, very good for the babies.”
“That’s a hard one,” Galindo said. “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”
Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old son, Hank, fell ill and was treated for botulism in March, weeks after he began drinking ByHeart. Being included in the investigation of the outbreak “feels like a win for all of us,” she said Wednesday.
“I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears — a mix of relief, gratitude and hope that the truth is finally being recognized,” she said.
In a statement late Wednesday, ByHeart officials said the company is cooperating with federal officials “to understand the full scope of related cases.”
“The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination,” the statement said.
Lab tests detected contamination
The FDA sent inspectors last month to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.
The company previously reported that tests by an independent laboratory showed that 36 samples from three different lots contained the type of bacteria that can cause infant botulism.
“We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company wrote on its website last month.
Those results and discussions with the FDA led CDC officials to expand the outbreak, according to Dr. Jennifer Cope, a CDC scientist leading the investigation.
“It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots,” Cope said. “They couldn’t isolate it to specific lots from a certain time period.”
Inspection documents showed that ByHeart had a history of problems with contamination.
In 2022, the year ByHeart started making formula, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for a different germ, cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”
A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just before FDA inspectors found problems with mold, water leaks and insects, documents show.
Infant botulism is rare
Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It’s caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin.
Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, according to research studies.
Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.
The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s infant botulism program developed the product and is the sole source worldwide.
The antibodies provided by BabyBIG are likely most effective for about a month, although they may continue circulating in the child’s system for several months, said Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital.
“The risk to the infant is ongoing and the family should not be using this formula after it was recalled,” Nachman said in an email.
Families of several babies treated for botulism after drinking ByHeart formula have sued the company. Lawsuits filed in federal courts allege that the formula they fed their children was defective and ByHeart was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.
Dec. 3, 2025:
UNDATED-AP- Nearly 40 babies have been sickened in an infant botulism outbreak tied to contaminated formula, federal health officials say.
The Food and Drug Administration on Wednesday (Dec. 3, 2025) reported 39 cases of confirmed or suspected illness in 18 states among babies who consumed ByHeart formula since August. The most recent illness occurred on Nov. 19.
No deaths have been reported in the outbreak, which was announced Nov. 8.
ByHeart, a New York-based manufacturer of organic infant formula, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.
Some ByHeart products are still on shelves at stores including Walmart, Target, Kroger, Acme and Shaw’s, despite the ongoing recall, the FDA reported.
It can take up to 30 days for symptoms of infant botulism to develop, medical experts said.
Nov. 20, 2025:
UNDATED-AP- As cases of potentially deadly botulism in babies who drank ByHeart infant formula continue to grow, state officials say they are still finding the recalled product on some store shelves.
Meanwhile the company reported late Wednesday (Nov. 19, 2025) that laboratory tests confirmed that some samples of formula were contaminated with the type of bacteria that has sickened more than 30 babies in the outbreak.
Tests by an independent food safety laboratory found Clostridium botulinum, a bacterium that produces toxins that can lead to potentially life threatening illness in babies younger than 1, the company said on its website. ByHeart officials said they notified the U.S. Food and Drug Administration of the findings but did not specify how many samples were tested or how many were positive.
“We are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again,” ByHeart said on its website.
The FDA did not immediately respond to questions about the findings.
The lab results come as investigators in at least three states found ByHeart formula still for sale even after the New York-based company recalled all products nationwide, officials told The Associated Press.
At least 31 babies in 15 states who drank ByHeart formula have been hospitalized and treated for infantile botulism since August, federal health officials said Wednesday. They range in age from about 2 weeks to about 6 months, with the most recent case reported on Nov. 13.
No deaths have been reported.
In Oregon, nine of more than 150 stores checked still had the formula on shelves this week, a state agriculture official said. In Minnesota, investigators conducted 119 checks between Nov. 13 and Nov. 17 and removed recalled products from sale at four sites, an agriculture department official said. An Arizona health official also said they found the product available.
Businesses and consumers should remain alert, Minnesota officials said in a statement. “No affected product should be sold or consumed,” they wrote.
Investigators with the U.S. Food and Drug Administration conducted inspections at ByHeart manufacturing plants in Allerton, Iowa, and Portland, Oregon. No results from the inspections have been reported.
California officials previously confirmed the germ that can lead to illness in an open can of ByHeart formula fed to a baby who fell ill.
Infant botulism, which can cause paralysis and death, is caused by a type of bacteria that forms spores that germinate in a baby’s gut and produce a toxin.
Symptoms can take up to 30 days to develop and include constipation, poor feeding, a weak cry, drooping eyelids or a flat facial expression. Babies can develop weakness in their limbs and head and may feel “floppy.” They can have trouble swallowing or breathing.
ByHeart had been manufacturing about 200,000 cans of formula per month. It was sold online or at retail stores such as Target and Walmart. A Walmart spokesperson said the company swiftly issued a restriction that prevented sale of the formula, removed the product from stores and notified consumers who had bought it. Customers can visit any store for a refund of the formula, which sold for about $42 per can.
Federal and state health officials are concerned that some parents and caregivers may still have ByHeart products in their homes. They are advising consumers to stop using the product — including formula in cans and any single-serve sticks. They also suggest marking it “DO NOT USE” and keeping it for at least a month in case a baby develops symptoms. In that case, the formula would need to be tested.
The California health department operates the Infant Botulism Treatment and Prevention Program, which tracks cases and distributes treatment for the disease. Officials there have launched a public hotline at 833-398-2022, which is staffed with health officials from 7 a.m. to 11 p.m. Pacific Standard Time.
The new hotline was created after calls from hundreds of parents and caregivers flooded a different, longstanding hotline for doctors to discuss suspected infant botulism cases, officials said.
Nov. 11, 2025:
UNDATED-AP- ByHeart, a manufacturer of organic baby formula, recalled all of its products sold nationwide Tuesday (Nov. 11, 2025), days after some batches were recalled in an expanding outbreak of infant botulism.
At least 15 babies in 12 states have been sickened in the outbreak since August, with more cases pending, according to state and federal health officials. All of the infants were hospitalized after consuming ByHeart formula, officials said. No deaths have been reported.
ByHeart officials expanded the voluntary recall from two lots announced Saturday to all products in consumers’ homes and in stores. That includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The company sells about 200,000 cans of infant formula a month online and in stores such as Target, Walmart, Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical officer.
Parents and caregivers who have the formula in their homes “should immediately discontinue use and dispose of the product,” Kuehn said.
Company officials said they enacted the unusual recall “in close collaboration” with the U.S. Food and Drug Administration “despite the fact that no unopened ByHeart product has tested positive” for the contamination.
California health officials earlier confirmed that a sample from an open can of ByHeart baby formula fed to an infant who got sick contained the type of bacteria that causes the toxin linked to the outbreak.
“This action underscores ByHeart’s core mission: protecting babies above all else,” the company said in a statement.
The U.S. Food and Drug Administration is investigating 84 cases of infant botulism detected since August. Of those, 36 consumed infant formula, with a more than a third who received ByHeart formula, the agency said in a statement.
“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 statement said.
ByHeart produces formula powder at a plant in Allerton, Iowa, and then ships it to a site in Portland, Oregon, for canning and distribution, Kuehn said. U.S. Food and Drug Administration inspectors were at the Portland plant Monday, she added.
In addition to the broad recall, the company said it is testing every batch of formula with an independent third-party laboratory, providing health officials full access to its sites and sharing results with regulators as they become available.
Infant botulism is a rare and serious illness that occurs in babies under age 1, whose gut microbiomes are immature. It is caused when the infants consume bacteria that contain spores that produce a toxin in the gut. Symptoms include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing and breathing problems, among others.
Babies who develop those symptoms need immediate medical attention. The sole treatment for the infection is BabyBIG, an IV medication made from blood plasma of people immunized against botulism.
Nov. 10, 2025:
UNDATED-AP- Preliminary tests showed that ByHeart baby formula contained the type of bacteria that produces the toxin linked to a botulism outbreak, California health officials said.
The outbreak has sickened at least 13 infants in 10 states. No deaths have been reported.
“Consumers in possession of this product should stop using it immediately,” the California Department of Public Health said in a statement late Saturday.
More tests of ByHeart Whole Nutrition Infant Formula are pending as state and federal health officials investigate the outbreak that started in mid-August. The New York-based company this weekend recalled two lots of the powdered product.
Here’s what to know about the outbreak and infant botulism.
Infant botulism outbreak
The outbreak of infant botulism has sickened babies aged 2 weeks to 5 months since mid-August. All were hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention.
The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
ByHeart officials agreed to recall two lots of the company’s Whole Nutrition Infant Formula, according to the U.S. Food and Drug Administration. The formula has a best-by date of December 2026.
California health officials tested a can of the powdered formula that was fed to a baby who fell ill. The results “suggest the presence” of the type of bacteria that produces the botulism toxin confirmed in other cases. It can take several days to confirm the results.
ByHeart officials said that “more testing is needed” to know whether the type of bacteria that causes botulism is present. It comes from a large family of bacteria, many of which are found naturally in the environment and don’t cause illness, the company said.
“We take this very seriously,” it said in a statement Sunday.
The FDA is investigating reports of 83 cases of infant botulism reported since August including the cases linked to ByHeart baby formula.
Causes of infant botulism
Infant botulism typically affects fewer than 200 babies in the U.S. each year. It is caused by a type of bacteria that produces toxins in the large intestine. The bacterium is spread through hardy spores present in the environment that can cause serious illness, including paralysis.
Infants younger than 1 are particularly vulnerable and can be sickened after exposure to the spores in dust, dirt or water or by eating contaminated honey.
Symptoms can take weeks to develop and can include poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.
No known outbreaks of infant botulism tied to powdered formula have previously been confirmed, said Dr. Steven Abrams, a University of Texas nutrition expert.
“This would be extremely rare,” he said.
Infant botulism treatment
The only treatment is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s Infant Botulism Treatment and Prevention Program developed the product and is the sole source worldwide.
BabyBIG works to shorten hospital stays and decrease the severity of illness in babies with botulism. Because the infection can affect the ability to breathe, infants often need to be placed on ventilators.
All of the children in the ByHeart outbreak have received the medication, the CDC said.
Potential impact on U.S. formula supplies
There is no danger of infant formula shortages because of this outbreak. ByHeart, which was founded in 2016, accounts for an estimated 1% of national formula sales, according to the CDC. The company sells formula through its website and in retail stores nationwide.
That’s different from the crisis in late 2021 and 2022, when four infants were sickened by a different germ after consuming formula made by Abbott Nutrition. Two of the babies died. No direct link was found between the Abbott products and the infections caused by cronobacter sakazakii, but FDA officials closed the company’s Michigan plant after contamination and other problems were detected.
Abbott recalled top brands of infant formula, triggering a massive nationwide shortage that lasted for months.
In 2022, ByHeart recalled five batches of infant formula after a sample at the company’s packaging plant tested positive for cronobacter sakazakii, the germ at the heart of the Abbott crisis. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”
Reviewing infant formula ingredients
Federal health officials have vowed to overhaul the U.S. food supply and are taking a new look at infant formula.
Health Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration to review the nutrients and other ingredients in infant formula, which fills the bottles of millions of American babies.
The effort, dubbed “Operation Stork Speed,” is the first deep look at the ingredients since 1998.
FDA officials are reviewing comments from industry, health experts and public to decide next steps.
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