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 June 30, 2026
New evidence reveals the powdered milk supplier that sickened infants who consumed Nara Organics infant formula was the same in the ByHeart botulism outbreak. The recall has pulled product from the market and no new cases have been reported. However, more investigation into the powdered milk supplier may help prevent future illnesses.
Are the Nara Organics and ByHeart infant botulism outbreaks related? What is infant botulism and why is it so dangerous? What is being done about the situation?
Here’s what we know so far about the powdered milk supplier and the Nara Organics infant formula botulism outbreak so far.
An infant botulism outbreak investigation was announced on June 13, 2026. Three babies (all requiring hospitalization) were diagnosed with infant botulism. Illnesses were reported between April and May 2026. The last date of illness onset was recorded on May 31, 2026. Sick babies were from California, Pennsylvania, and Washington.
All three babies consumed the same infant formula.
Nara Organics.
Several updates have been made regarding the outbreak. Including the recall and additional testing.
Prior to (and unrelated) reported illnesses, the FDA inspected the two European facilities that manufacture Nara Organics Whole Milk Organic Infant Formula.
Observations and deficiencies were cited at both facilities. The results of those corrective actions are currently under review.
Meanwhile, sample testing is in progress to better understand the outbreak.
According to the U.S. Food and Drug Administration (FDA) health officials in two states collected leftover infant formula. That testing is underway and the results should be available soon.
The FDA also collected unopened containers of lot numbers fed to affected infants. Samples of those products are being tested. The results are expected in the coming weeks.
The FDA traceback investigation found that the infant formula lots linked to outbreak patients were made with the main ingredient from the milk supplier, Organic West Milk. This milk was spray dried by the Dairy Farmers of America.
These are the same suppliers of organic whole milk and organic whole milk powder used by ByHeart in the November 2025 ByHeart powdered infant formula botulism outbreak. However, the FDA says, “currently there is not enough evidence to determine if this is the source or route of contamination.”
However, it seems that the recall from Organics West Milk allowed information (and potentially contaminated product) to slip through the cracks.
As part of the 2025 Infant Botulism outbreak, the FDA conducted a “traceforward” investigation. They requested a list of powdered infant formula manufacturers Organic West Milk provided the ingredients to. At the time, Nara Organics was not on that list. However, Organics West Milk did not provide a complete customer list.
This information was only revealed during this current investigation.
Infant botulism is caused by a bacterium called Clostridium botulinum. A germ associated with contaminated food and dust particles. It produces a toxin that can cause serious digestive upset in young children and adults. However, it impacts the underdeveloped digestive system of infants quite differently.
Botulism is often associated with improperly sterilized or inadequately processed or refrigerated home-canned and preserved food. Though honey exposure accounts for around 20% of cases. For this reason, some populations present a higher incidence of botulism due to the increased use of herbal medications and raw honey.
The 2025 infant botulism outbreak linked to ByHeart infant formula was the first time it had been associated with that food item. However, since then it has been infant formulas have been linked to other outbreaks. The current Nara Organics and a2 Milk Company for a different toxin, cereulide (produced by Bacillus cereus bacteria).
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.”
Antibiotic therapy is typically not administered in infant botulism. Instead, an anti-toxin called BIG-IV is administered.
This single-dose treatment is administered intravenously over 30 minutes. This treatment can rapidly improve symptoms. Particularly if administered within 24 hours of infant botulism symptoms onset. However, it is quite expensive.
A dose of BIG-IV is upwards of $50,000. In California, this “per patient fee” is $69,300!
Additionally, around half of infant botulism cases require intubation and an advanced airway. Without this anti-toxin treatment, infected infants often require mechanical ventilation for longer periods.
So, what is being done about the situation right now?
The investigation is still active and ongoing. Affected infants are receiving appropriate treatment, a recall has already taken place and products are no longer available for purchase.
Testing is still in progress. When the results are available, the FDA will likely release the information and the Make Food Safe Blog will update our readers.
I suspect the next step in the process is an investigation into the powdered milk supplier and the milk supplier they used.
Infant botulism should be taken very seriously. If you suspect your baby has infant botulism, there are a few things you can do to help.
Botulism can be fatal if not treated right away. Your physician should notify the Infant botulism treatment and Prevention Program hotline at 510-231-7600 for a case consultation. The line is available 24/7.
If possible, retain a portion of the product (carefully bagged up and labeled so it is no longer consumed). This could be useful if investigators wish to test a sample from your opened container.
Otherwise, document lot information for the product that was consumed to be used in the traceback investigation process.
If your child has been impacted by infant botulism after consuming infant formula, it is a good idea to get legal advice. A Food Poisoning Lawyer understands product contamination and product liability cases and can help you through this difficult process.
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)