California finds presumptive Clostridium botulinum in can of powdered infant formula fed to outbreak victim

The California Department of Public Health (CDPH) has tested a can of ByHeart powdered infant formula that was fed to an infant who later developed infant botulism. Preliminary results indicate the presence of botulinum toxin-producing bacteria in the sample consisten with the type of toxin reported from confirmed outbreak cases.

As of November 8, 2025, 13 infants with suspected or confirmed infant botulism have been reported from 10 states, according to the CDC: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.

Eight of the 13 cases have been confirmed as Type A botulism; the remaining five cases are still under investigation. Illnesses started on dates ranging from mid-August to November 2025. All 13 infants were hospitalized and treated with BabyBIG® (an antitoxin for infant botulism developed and supplied by the CDPH). No deaths have been reported. Infants ranged in age from 16 to 157 days.

Interviews conducted with caregivers for the 13 outbreak victims revealed that all 13 (100%) infants were fed ByHeart Whole Nutrition infant formula.

In response to the findings, ByHeart Inc. has recalled the following two batches of ByHeart Whole Nutrition Infant Formula (UPC: 5004496800):

Batch Code: 251261P2, Use by: 01 Dec 2026
Batch Code: 251131P2, Use by: 01 Dec 2026

ByHeart’s inspection history

ByHeart Inc. is the parent company for three manufacturing / packaging facilities:

Blendhouse LLC (Reading, PA), a manufacturing site
Blendhouse Allerton, LLC (Allerton, IA), a manufacturing site
Blendhouse Portland LLC (Portland, OR), a packaging site

Of these, the Reading facility manufactures the infant formula base product, which is then blended and packaged at a different facility.

The Reading location achieved its FDA registration on April 28, 2022 and was subjected to an initial, and successful, FDA inspection in June of 2022.

Then, the Cronobacter sakazakii tsunami hit, and the FDA chose to take an in-depth look at all of the powdered infant formula manufacturing sites, including ByHeart’s Reading facility. What they found was disturbing, resulting in both inspections being classified as “Official Action Indicated.”

Inspection end date February 17, 2023

The FDA investigation team uncovered numerous problems, which were summarized in a Warning Letter, dated August 30, 2023. These included

Lack of process control system, as evidenced by a finding of Cronobacter sakazakii in a batch of ByHeart Whole Nutrition Infant Formula finished product. The infant formula base which was incorporated into that batch had been manufactured in continuous process from July 13, 2022, through August 23, 2022.
Discrepancy between company’s root cause analysis of the Cronobacter contamination problem and the conclusion of the third-party lab, in which the company blamed lab error and the lab denied that they had erred.
Multiple notifications from third party lab of positive Cronobacter sakazakii findings from July 25, 2022, through August 27, 2022 within the processing environment.
Two water events, during which water leaked into the manufacturing areas from outside.

Inspection end date January 19, 2024

The FDA conducted its next inspection eleven months later. According to information posted on the FDA’s inspection data dashboard, investigators uncovered several serious problems.

did not implement a system of production and in-process controls for an infant formula
did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
did not minimize the potential for contamination of raw materials through the use of appropriate measures
did not ensure that all surfaces that contacted ingredients, in-process materials and infant formula were cleaned and sanitized and maintained to protect infant formula from being contaminated by any source
did not monitor the temperature in a thermal processing equipment at a point where temperature control is necessary to prevent adulteration.
did not exclude pests from your food plant to protect against contamination of food.

Tempest in a teapot?

The ByHeart recall notice appears to make light of the probability that the company’s products are the source of the 13 cases of infant botulism, stating, “The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.”

However, Clostridium botulinum is a common inhabitant of soil. This spore-forming bacterium also is relatively resistant to heat, and has the ability to endure long exposure to dry conditions. Poor sanitation, inadequate temperature control, and inadequate pest control are all routes by which this microbe can find its way into a powdered product.

Infant botulism, unlike the form of the ailment that attacks the general population, does not require pre-formed toxin to be present in the product. An infant’s digestive system can become infected by spores that are ingested or inhaled and set up an infection in the intestine.

In 2005, researchers in the United Kingdom described a case of infant botulism that appeared to be linked to consumption of contaminated powdered infant formula, even recovering a strain of Clostridium botulinum from a sample of the formula. However, in that case, genetic profiling suggested that the strain recovered from the formula was not the same as the one responsible for the illness.

Most prior cases of infant botulism have been traced to ingestion of soil or honey products. Nevertheless, caregivers and medical professionals must be on the alert. Untreated, infant botulism can be deadly. It should never be taken lightly.

What caregivers should do

Do not use recalled infant formula. Throw it away or return it to where you bought it.
- If possible, record the lot number.
Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
- Poor feeding
- Loss of head control
- Difficulty swallowing
- Decreased facial expression
Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots of infant formula.

What clinicians should know

Initial diagnosis of infant botulism is based on clinical symptoms.
Consultation with the Infant Botulism Treatment and Prevention Program is available for suspected cases. If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.
If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.

Symptoms of infant botulism

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing.
If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.

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Powdered Infant Formula linked to infant botulism outbreak

The FDA, CDC, California Department of Public Health and state and local partners are investigating a ten-state outbreak of infant botulism that has sickened 13 infants so far.

Caregivers for all thirteen infants reported feeding ByHeart Whole Nutrition infant formula.

Illnesses have been reported in Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). These totals include both suspected and confirmed cases.

The thirteen victims range in age from 16 to 157 days. All thirteen have been hospitalized and treated with BabyBIG®, an antidote to infant botulism.

Several states have collected leftover samples of infant formula for testing; work is in progress, but the results are not yet available.

The FDA has recommended that the manufacturer, ByHeart Inc., initate a recall. The company has complied and is recalling the following two lots, which were reported to have been consumed by the infants:

ByHeart Whole Nutrition Infant formula:- Lot no. 206VABP/251261P2 and Lot no. 206VABP/251131P2)

What consumers and caregivers need to know

How to identify infant botulism

Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby’s large intestine and make toxin in it.

Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone. Symptoms can progress to difficulty breathing and respiratory arrest.

Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

What actions to take

Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.
If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.

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Botulism and baby food. The Oceanitan affair

On January 24, 2023, the Missouri Department of Health and Human Services alerted the US Food and Drug Administration (FDA) to a possible case of Clostridium botulinum in an infant.

Although primarily breastfed, the infant had also been fed some packaged refrigerated baby food on or around January 7th (pumpkin) and January 11th (broccoli). On January 18th, the infant began to show symptoms of botulism.

By January 22nd, the infant had been hospitalized, and treatment with an anti-toxin was initiated.

The treatment was successful and the infant survived.

The baby food was manufactured by Oceanitan, LLC, a contract manufacturer of baby food products located in Los Angeles, California.

The investigation

On February 3rd, a Missouri health inspector collected samples of the product from the infant’s home and submitted them to the FDA for analysis.

On February 16th, with the lab analysis underway, the FDA began an in-depth inspection of Oceanitan’s manufacturing facility—an inspection that would continue into early April.

The inspection revealed multiple, serious violations of various federal standards (“rules”) for safe manufacture of food products. These violations included:

Lack of preventive controls for bacterial growth and/or toxin formation by Clostridium botulinum in the finished, packaged ready-to-eat products
Use of uncalibrated and inaccurate thermometers to measure storage temperatures
Exposure of cooked ingredients and products to potential environmental contamination during cooling, production, and packaging
Lack of an environmental monitoring program
Inadequate sanitation controls procedures
Lack of a validation study to support cooking parameters specified in the written Process Control document
Dripping water, exposed rust, and peeling paint in various areas of the manufacturing facility

While the inspection was still in progress, the FDA laboratory completed its analysis. The products collected by the Missouri inspector from the home of the sick infant were contaminated with both a non-toxin strain of Clostridium botulinum and a strain of Clostridium beijerinckii.

Although both of these strains were non-pathogenic, they represented clear evidence that a toxin-producing strain of Clostridium botulinum would have been fully capable of growing in the baby food. The lab also reported that the pH and water activity of these products were well within the range to promote growth of the pathogen.

The follow-up

In keeping with the agency’s standard operating practice, the FDA investigator met with company management on April 6th at the completion of the inspection to make a formal presentation of FDA Form 483 (Inspectional Observations) and review the documented violations.

On April 27th, Oceanitan’s Chief Executive Officer, Nelson Lee, responded in writing to the list of observations. He informed the FDA that the company had purchased calibrated temperature data monitors for its coolers, contracted a third-party lab to initiate an environmental monitoring program, updated its sanitation program, cleaned and repaired ceilings and walls, and initiated steps to have other repairs performed by an outside contractor.

After reviewing the company’s response, the FDA issued a Warning Letter on September 7, 2023. In its letter, the agency noted that Oceanitan had not taken steps to update its hazard analysis or implement written procedures for monitoring a preventive control. Nor did the company provide a validation study for its process control parameters.

The FDA gave Oceanitan fifteen working days from receipt of the letter to notify the agency in writing of the steps it was taking to correct the remaining violatiosn and prevent a recurrence, and also advised the company that the agency would be conducting a follow-up inspection to determine Oceanitan’s compliance with the requirements of the Federal Food, Drug, and Cosmetic Act and its asssociated regulations.

Botulism—Infant and otherwise

Botulism is not a common occurrence.

In 2019, the most recent year for which data are posted on its website, the US Centers for Disease Control and Prevention (CDC) reported 152 cases of infant botulism and just 21 cases of foodborne botulism.

That same year, the CDC logged 58,371 non-typhoidal Salmonella reports and 16,939 reports of shiga toxin-producing E. coli.

Infant botulism can be associated with consumption of honey that is contaminated with spores of Clostridium botulinum. In fact, in Canada, raw honey is the only food that has been specifically linked to infant botulism.

In foodborne botulism, individuals become ill from eating a food that contains pre-formed toxin. But in the case of infants, it’s not necessary for the toxin to be present in the food. Clostridium botulinum spores can multiply and produce their deadly toxin in the baby’s intestine.

The take-aways

The baby food products manufactured under contract by Oceanitan were neither commercially sterile nor shelf-stable.

The products were sold as refrigerated, “ready-to-eat” baby foods.

Information on the brand(s) of baby food products manufactured by Oceanitan was redacted from the documents obtained by eFoodAlert under the Freedom of Information Act, as this information is considered to be proprietary.

The manufacturing process consisted of cooking the individual ingredients before they were mixed and puréed. There was no second “kill” step either before or after the products were filled into their 4-ounce plastic jars. And there were serious flaws in the company’s hazard analysis, environmental monitoring, and facility maintenance.

By neglecting fundamental principles of safe food manufacture, the company and its commercial customers put a vulnerable population at risk.

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