ByHeart Infant Formula Recalled for Botulism Risk
Thirteen infants have been hospitalized in 10 states. No deaths have been reported.
Two lots of ByHeart infant formula have been recalled after 13 infants fed ByHeart formula were hospitalized with infant botulism across 10 states. A public health investigation is underway after a can of ByHeart infant formula was found to contain bacterial spores that can cause infant botulism.
If you have any cans of ByHeart Whole Nutrition Infant Formula, check for the following lot codes printed on the bottom of the can: 251261P2 and 251131P2. Both lots have use-by dates of 01 Dec 2026. If you have the recalled formula, stop using the formula immediately. If your child has consumed ByHeart formula and is showing signs of botulism, such as muscle weakness, poor feeding, loss of head control, or difficulty swallowing, seek immediate medical care.
The California Department of Public Health tested one can of previously opened powdered infant formula and found it to suggest the presence of C. botulinum, though further testing is underway. Given the ongoing investigation, the CDPH recommends not discarding the product without first checking with your state or local health department.
What Is Infant Botulism?
Infant botulism is one of five types of botulism that are primarily caused by a neurotoxin produced from the spores of Clostridium botulinum.
Infant Botulism Symptoms
In babies, symptoms of infant botulism can take weeks to appear, but may initially include constipation and difficulty feeding. It can progress to loss of muscle tone and difficulty breathing. It’s most common in babies under 12 months of age.
Symptoms of infant botulism may include:
• Constipation.
• Poor feeding, including difficulty sucking and swallowing.
• Loss of head control.
• A weak and altered cry.
• Diminished facial expression, including drooping eyelids and sluggish pupils.
• Other signs of muscle weakness.
• Breathing difficulty.
Botulism is a medical emergency. If you’re noticing any of the above symptoms in your baby, seek prompt medical attention.
Infant Botulism Treatment
Infant botulism can be treated with an antitoxin known as BabyBIG, which can be requested from the CDPH, the world’s only producer of the antitoxin. After noticing a spike in treatment requests that were all linked to ByHeart formula, California public health officials notified the CDC of a possible outbreak.
How Could the Botulism Toxin Get Into Infant Formula?
The presence of C. botulinum is rare in infant formula, but it’s important to note that powdered infant formula is not considered to be sterile, unlike ready-to-feed formula. The spores can be naturally found in the environment, including in soil, dust, and some vegetables.
“It is possible that the spores from C. botulinum came from contaminated ingredients or from the environment,” says James E. Rogers, PhD, Consumer Reports’ director of product and food safety research and testing, whose team led CR’s testing on infant formula contaminants in early 2025. “And even if the product is heat-treated to kill or reduce the number of live bacteria, C. botulinum spores are heat-resistant and would survive the process.”
Is Infant Formula Tested for the Botulism Toxin?
The Food and Drug Administration requires that formula makers test for cronobacter and salmonella species in the finished product, Rogers says. According to ByHeart, testing for the C. botulinum toxin is not part of current practice among formula manufacturers.
“Currently, global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum,” Devon Kuehn, MD, ByHeart chief medical officer and chief scientific officer, told CR by email. Kuehn also said no U.S. or global infant formula company is required to test for the toxin. “We adhere to the rigorous safety and quality standards and have the utmost confidence in our product, in our safety systems, and in the people behind them,” she said.
About the ByHeart Infant Formula Recall
Thirteen cases of infant botulism have been reported in the following states. All cases have a direct link to ByHeart formula, though testing is ongoing. In 2022, five lots of ByHeart infant formula were recalled after a sample tested positive for Cronobacter sakazakii—rare but dangerous bacteria.
States where infant botulism cases have been reported among infants consuming ByHeart formula:
• Arizona
• California (2 cases)
• Illinois (2 cases)
• Minnesota
• New Jersey
• Oregon
• Pennsylvania
• Rhode Island
• Texas (2 cases)
• Washington
Details of the ByHeart Infant Formula Recall
The recalled formula was sold at ByHeart.com and at major retailers nationwide, the FDA says. ByHeart is sold at Amazon, Kroger, Sam’s Club, Target, Walmart, and Whole Foods, among other stores. The illnesses were first reported in August 2025, with the last illness onset reported in November 2025.
Lot Numbers Recalled
• Batch Code: 251261P2; use-by date: 01 Dec 2026
• Batch Code: 251131P2; use-by date: 01 Dec 2026
• UPC: 5004496800
The problem: 13 infants across 10 states who have consumed ByHeart powdered infant formula have been hospitalized with infant botulism.
Company response: In a statement on the company’s website, ByHeart says that “testing from a previously opened can lacks scientific basis to establish causation between the product and illness.”
The company says that it has enlisted a third-party independent testing laboratory to test the two recalled batches of infant formula from unopened cans and is awaiting expedited results. “These results will confirm if C. botulinum bacteria is present in ByHeart’s infant formula,” Kuehn said in an email to CR. “We commit to sharing these results as soon as they become available.”
“We take the California Department of Public Health’s (CDPH) results seriously and we are actively working in partnership with CDPH, FDA, and CDC on their comprehensive investigation,” Kuehn said. “We are committed to getting to the bottom of it.”
According to publicly available data from the FDA, a January 2024 inspection by the FDA of ByHeart’s Pennsylvania infant formula manufacturing facility resulted in several citations for unsanitary conditions and the potential for contamination of raw materials at the facility. There was also a citation for lack of pest control.
“It’s very troubling that ByHeart appears to not have adequately addressed the FDA’s concerns over the serious problem involving unsanitary and contamination risk conditions at their plant,” says Brian Ronholm, head of food policy for CR. Drastic budget cuts and a federal government shutdown also limit the “ability of regulators to manage how the outbreak is communicated,” Ronholm says. It’s unclear how long the ByHeart formula investigation may take.
What consumers can do next: Stop using any cans with the recalled batch codes and check with your local health department before disposing of the cans. You can email ByHeart at hello@byheart.com for information, or call 833-429-4327.
If you have recalled formula, wash any items or surfaces that may have come into contact with the formula using hot soapy water or in a dishwasher, the CDC says.
To report an illness, contact your state’s local health department, fill out the FDA’s MedWatch Online Voluntary Reporting Form, or call an FDA Consumer Complaint coordinator.
An infant formula shortage is not likely. According to the FDA, ByHeart produces approximately 1 percent of the nation’s infant formula, and this recall is not expected to cause a formula shortage or drastically affect the country’s formula supply.
As a reminder, medical experts strongly advise against making your own baby formula because it can result in dangerous nutritional deficiencies or contamination.
Learn more about how Consumer Reports tests infant formula for contaminants such as heavy metals, acrylamide, and bisphenol A (BPA), and find the products that exceed our safety expectations.
