IEH Laboratories & Consulting Group, a third-party laboratory hired by ByHeart Inc. to test its powdered infant formula has recovered Clostrodium botulinum from an unspecified number of samples.
IEH tested sealed cans of ByHeart’s powdered infant formula, thus confirming that the contamination came from the product and was not as a result of consumer mishandling of the powdered formula during preparation or storage.
In a letter addressed “To families everywhere,” and posted on the company’s website, ByHeart did not reveal how many samples tested positive, or whether the positive samples represented more than one production lot.
On November 19, 2025, the CDC posted an update on its investigation into the infant botulism outbreak linked to ByHeart infant formula, announcing that 31 confirmed and suspect cases have been identified so far.
Unlike the better known form of botulism that results from ingesting of a pre-formed toxin, infant botulism occurs when a baby ingest spores of Clostridium botulinum. The spores travel through the stomach, grow and produce there toxin in the infant’s intestine.
To date, the Marler Clark law firm has filed three separate complaints against ByHeart Inc. on behalf of families whose infants were hospitalized after being fed the company’s infant formula.
Typical initial symptoms of infant botulism can include: poor feeding, loss of head control, difficulty swallowing, and decreased facial expression. If untreated, infant botulism can be deadly.
ByHeart has pledged to work with the FDA to identify the root cause of the Clostridium botulinum contamination.
Consumers need to be aware that, even though ByHeart did not distribute its products internationally, their infant formula was available for sale online. Both Canada and Trinidad and Tobago have issued warnings to consumers in those countries to avoid feeding ByHeart powdered infant formula to their infants.
According to the FDA, customer information provided by Amazon shows that a limited quantity of recalled ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and Virgin Islands.
What caregivers need to know (per CDC)
Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
If possible, take a picture or record the lot number and best by date.
If you have leftover ByHeart powdered formula, label it “DO NOT USE” and keep it stored in a safe place for at least a month.
If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
Wash items and surfaces that may have touched the 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 ByHeart Whole Nutrition infant formula.
California Department of Public Health has a public hotline to support caregivers with concerns about this outbreak and infant botulism.
Available Monday to Sunday, 7 a.m. to 11 p.m. Pacific Standard Time
1-833-398-2022
“Reads like a true crime novel” – Food Safety News
Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?
Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.
When seven Democrat senators and one independent sided with the Republican majority to pass a bill meant to end the government shutdown earlier this week, they did so in full knowledge that they were throwing Affordable Care Act premium subsidies under the bus.
Mike Johnson already has signaled that a vote in the Senate in favour of extending those subsidies would not guarantee a vote in the House.
But, did they realize that, by voting for the Republican bill, they were also throwing food safety under the wheels of that same bus?
According to The Lever, as reposted by Bill Marler (tip of the Petri dish lid for finding and sharing this), the Senate-approved language guts funding for certain current and planned FDA programs and Rules.
The Traceability Rule
Ironically, this Rule was first proposed under Trump 1.0 and is designed to simplify the tracing of a food to its source during a recall or foodborne disease outbreak investigation.
The Rule, which was finalized in 2023, requires food manufacturers, processors, packers, etc., “…maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods.”
The FDA allowed three years (ie., until January 2026) for those affected by the Rule to come into compliance with its requirements.
Last August, the FDA proposed to extend the compliance deadline by 30 months, to July 2028.
A provision of the Senate bill specifies that no funds “…may be used to administer or enforce the ‘Requirements for Additional Traceability Records for Certain Foods,’ published on Nov. 21, 2022.”
Produce Safety
In 2016, the FDA issued a Final Rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” in response to a steady increase in foodborne disease outbreaks linked to contaminated produce.
Compliance dates for this Rule were staggered, with the smallest farms given until 2020 to conform.
The Senate bill just passed PROHIBITS any of the funding made available by the bill from being used to enforce the Produce Safety Rule.
Sodium / Ultraprocessed foods
Finally, in the ultimate irony of the MAHA world, the Senate bill slashes funding for the FDA to develop or administer regulations “…long-term population-wide sodium reduction actions until an assessment is completed on the impact of the short-term sodium reduction targets.”
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
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 sakazakiiin 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.
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.
“Reads like a true crime novel” – Food Safety News
Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?
Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.
eFoodAlert 