Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Botulism,Our Blog,Outbreaks & Recalls on December 4, 2025
The U.S. Food and Drug Administration (FDA) recently published the latest inspection reports for three ByHeart Facilities. One of which has ceased supply to the blendhouse responsible for packaging final product sent out for distribution. Major violations were observed at that facility. Other violations were observed at the other two.
Curious about what was in those reports?
Three ByHeart facilities are responsible for all of the infant formula produced by the company. Two that produce the infant formula base powder and one that blends the base powder with other ingredients and packages it.
Two of the ByHeart facilities were inspected during routine surveillance activities. But one, the Reading facility, was inspected as a follow-up to a Warning Letter that was issued following serious citations during their previous inspection.
Here is what inspectors found!
The Allerton blendhouse facility was last inspected in February 2025. This facility manufactures the bulk infant formula base powder for the parent company ByHeart. According to the report, all ingredients are included in this base powder except for lactoferrin (which is added at the sister facility in Portland, Oregon).
Three major observations were made during this inspection:
Other issues included problems with “significant pest activity,” lack of routine environmental swabs and procedures in place to ensure proper actions are taken if a swab is positive for a pathogen. As well as other sanitation problems, like obvious rust and water stains caused by a previous “water event.”
The Reading Blendhouse, located in Reading, Pennsylvania inspection took place between December 2023 and January 2024 as a follow-up to an FDA Warning letter that was issued “due to significant violations” of “infant formula requirements.”
The previous inspection took place between December 2022 and February 2023, which was classified as “Official Action Indicated” (OAI).
Two major observations were noted in the report:
Other notable problems included unsanitary contact surfaces and production areas, visible mold growth, the presence of pests (including both live and dead flies in the dryer room and packing room), improper temperature control, roof leaks, multiple water leaks, and standard operating procedure deficiencies.
This facility has not been operational since September 2023.
The Portland blendhouse facility is located in Portland, Oregon and manufactures a single infant formula product for the parent company, ByHeart. This facility receives infant formula base powder, blends in lactoferrin, and fills metal cans and single serving size stick packs.
While this facility has received base powder from the Reading facility in the past, reports indicate that no product has been received from that facility since 12/01/2023.
This inspection took place in March 2025 for routine surveillance.
Their only major observation during the inspection involved a calibration procedure. However, during the inspection there were two positive swabs for Cronobacter. One swab was taken per protocol following an unplanned “water event,” following the use of a wet saw by a contractor to cut a hole in the wall. The other sample was obtained during routine sampling of the floor between two dock doors.
Normally, these records are not available to the public. In fact, the published reports are full of redactions. So they are still not completely available to the public. Specific layouts, protocols, and processes were blacked out. Likely for proprietary protections.
We are only able to see these inspection reports now due to transparency afforded to the public by the FDA in response to a tragic infant botulism outbreak.
As of December 3, 2025, at least 39 babies who have consumed ByHeart Whole Nutrition infant formula have been diagnosed with infant botulism. According to the California Department of Health, the number of infants potentially affected are reaching 200. Each week, more cases are added to the outbreak table.
So far, the outbreak has reached 18 states.
Texas has been the hardest hit with seven to eight cases. Followed by California with five to six. Arizona and Oregon have three to four cases each. Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Pennsylvania, Rhode Island, Virginia, Washington, and Wisconsin each have one to two cases per state.
Infant botulism is an intestinal illness that develops when spores of the bacterium Clostridium botulinum (or a related species) have been swallowed.
The spores can temporarily colonize the infant’s large intestine and produce a type of neurotoxin called botulinum neurotoxin. This neurotoxin can have serious or even fatal consequences if not treated quickly.
This type of botulism rarely affects people over a year old. This is because the natural bacteria in a healthy digestive tract prevents botulism-causing bacteria from lingering in the intestines. The undeveloped gut microbiome of those under one year is not strong enough to do this. Because the infection is different, symptoms often appear differently too.
When people over a year get sick with botulism, it is usually caused by consuming a food already contaminated with the toxin. It is the toxin that makes the individual sick. Not the bacteria itself.
For those under a year old, toxin is produced inside the body. Which explains the slow onset, as opposed to rapid symptoms observed in older children and adults.
According to The Cleveland Clinic, infant botulism presents as a slow form of paralysis in infants. It gradually worsens over time, making it quite difficult to identify early. You have an infant that is already at early developmental stages and does not have the ability to tell you what is going on. It is difficult to catch early.
Symptoms are difficult to discern. This is because infected babies are usually alert, have no fever, and appear otherwise healthy. Otherwise healthy except they become “floppy” and have difficulty holding their head up.
So, how do you know if your infant has symptoms?
Babies with infant botulism may experience any combination of symptoms associated with the illness.
Some of the common symptoms may include:
According to the U.S. Centers for Disease Control and Prevention (CDC) “symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.”
If your baby has consumed ByHeart infant formula and has been diagnosed with infant botulism, you are experiencing the unthinkable. You need an experienced foodborne illness lawyer to get you the help you need and answer questions about your situation.
The experienced Food Poisoning Lawyers at The Lange Law Firm, PLLC are dedicated to holding food companies accountable for lapses in food safety that result in illness or injury. They have recovered millions of dollars in product liability and food poisoning cases.
They can help you too!
Call (833) 330-3663 for a free, no obligation consultation. Or fill out the online submission form, and someone will get back with you right away.
By Heather Van Tassell (contributing writer, non-lawyer)