All ByHeart Infant Formula Recalled for Botulism Risk

Infant botulism is one of five types of botulism that are primarily caused by a neurotoxin produced from the spores of Clostridium botulinum. 

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 can be treated with an antitoxin known as BabyBIG, which can be requested from the California Department of Public Health (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. 

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.”

The FDA 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.

Fifteen 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, a rare but dangerous bacterium.

States where infant botulism cases have been reported among infants consuming ByHeart formula:
• Arizona
• California (two cases)
• Illinois (two cases)
• Kentucky
• Minnesota
• New Jersey
• North Carolina
• Oregon
• Pennsylvania
• Rhode Island
• Texas (two cases)
• Washington

The recalled formula was sold at byheart.com and at major retailers nationwide, the FDA says. ByHeart is sold at Amazon, Kroger, Walmart, Whole Foods, Target, and Sam’s Club, among other retailers. The illnesses were first reported in August 2025, with the last illness onset reported in November 2025.

Lot Numbers Recalled 
• All lots of ByHeart infant formula are being recalled.
• All packages, including both cans and single-serve “Anywhere” sticks, are being recalled.

The problem: 15 infants across 12 states who have consumed ByHeart powdered infant formula have been hospitalized with suspected or confirmed cases of infant botulism.

Company response: The CDPH confirmed that one previously opened sample of formula from one of the initial recalled batches tested positive. In a statement on the company’s website, ByHeart said that “testing from a previously-opened can lacks scientific basis to establish causation between the product and illness.” 

The company said that it has enlisted a third-party independent testing laboratory to test infant formula from unopened cans and that so far, no unopened cans of formula have tested positive for C. botulinum. But additional testing is underway. 

“We take the CDPH’s 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.”

“Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product,” the FDA said in the recall announcement.

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. The FDA sent ByHeart a warning letter in 2023 reflecting similar concerns after the 2022 recall for Cronobacter sakazakii risk.

“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 ByHeart formula and switch to a new baby formula immediately. Write down or photograph the lot numbers of formula and store it securely for 30 days, or check with your local health department before disposing of it. You can reach out to hello@byheart.com for information, or call 833-429-4327. 

If you have recalled formula, wash all items and surfaces in hot soapy water or in a dishwasher, the CDC says. Consider throwing out any bottles or feeding items that may have come into contact with the formula and replacing them.

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. 

If you were using ByHeart formula to feed your baby, it’s important to switch to a different formula right away because of the risk of infant botulism, medical experts say. Switching your baby’s formula can feel stressful, but it’s important not to panic. Infant botulism is rare, and even if your baby drank formula contaminated with botulism spores, it’s not a guarantee that they will automatically develop infant botulism. “That’s because the spores have to grow and release toxin inside the intestines for illness to occur, and that chain of events rarely happens,” says Mona Amin at Peds Doc Talk. “The risk is higher with exposure, but it’s far from certain.” Keep watching them, stay in touch with your pediatrician, and try not to panic, she says.

To minimize the risk of exposure, it’s best to make an immediate switch rather than trying to switch gradually. Most babies do fine switching between formula brands when needed, according to the CDC. 

Here’s how to ensure a smooth transition when switching formula: 
• Offer the new formula when your baby is the most hungry, typically the first feed of the day.
• Stick to your normal feeding schedule and routines to minimize other changes.
• Watch your baby for signs of how they’re digesting the new formula. Spit-up, fussiness, gas, and looser stools can all be normal as your baby adjusts. Severe signs like rash, hives, forceful vomiting or blood in their stool can be a sign that they are having an adverse reaction to their new formula. 
• Stay patient: It can take seven to 10 days for your baby to fully adjust to a new formula. It’s best to minimize other feeding changes or new foods during this transition.

If you have specific questions about your baby’s formula or nutrition, your pediatrician is your best resource.

Choosing a new formula? CR’s baby formula buying guide has expert-backed information on what to look for. Read more about how CR tests infant formula.

If you have any ByHeart baby formula, the CDC recommends washing any baby bottles and other items or surfaces that may have come into contact with the formula using hot, soapy water or in a dishwasher cycle. Because the dormant spores of C. botulinum are particularly heat-resistant and are able to survive in temperatures up to 250° F, if you’re concerned about potential exposure to C. botulinum spores, you may consider throwing out any bottles, nipples, and pacifiers that have come into contact with the powdered infant formula and replacing them with new ones. 

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 doing so 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 BPA, and find the products that exceed our safety expectations.