Category: food safety

ByHeart warns all product lots may be contaminated

In an update posted on the company’s website, ByHeart is warning its customers that “…all ByHeart formula across all product lots…” may be contaminated with Clostridium botulinum.

The warning comes after the company’s third-party testing lab (IEH IEH Laboratories & Consulting Group) found Clostridium botulinum in three out of three production lots. Five out of 36 samples tested were positive for the pathogen.

On November 11, 2025, ByHeart expanded an earlier product recall include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™. The recalled products were distributed on-line and nationwide across the United States, including Guam and Puerto Rico.

Information provided to the FDA by Amazon indicates that a limited quantity of recalled products also were 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.

As of November 19, 2025, the CDC reported 31 confirmed and suspected cases of infant botulism associated with consumption of ByHeart powdered infant formula. The affected infants range in age from 16 to 200 days.

In its communication to parents and caregivers, ByHeart has issued the following advice and information:

We want to reaffirm the critical direction for parents and caregivers to stop using ByHeart formula immediately. We continue to strongly recommend monitoring for symptoms of infant botulism and to contact a medical professional immediately if your child develops symptoms.

  • According to the American Academy of Pediatrics, the sign of Infant Botulism appears at an estimated 3 to 30 days from the time of consumption of the Clostridium botulinum bacteria.
  • Symptoms often begin with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy. 
TAINTED formats 3
“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.

Chapter 6. Birth of a Pathogen
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Clostridium botulinum found in sealed cans of ByHeart infant formula

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
TAINTED formats 3
“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.

Chapter 6. Birth of a Pathogen
Order TAINTED now from your preferred on-line retailer

What price compromise?

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.” 

Making Americans Sick Again

As it happens, I am in the throes of writing a sequel to my food safety book, TAINTED: From Farm Gate To Dinner Plate, Fifty Years of Food Safety Failures.

The planned title of my new book is, TAINTED II: From Baby Food To Seniors’ Snacks, Making Americans Sick Again.

Watch for it.

TAINTED formats 3
“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.

Chapter 6. Birth of a Pathogen
Order TAINTED now from your preferred on-line retailer