- Federal health officials say a multi-state infant botulism outbreak linked to ByHeart formula may have originated from contaminated whole milk powder supplied to the company.
- ByHeart recalled all batches of its infant formula in November after Food and Drug Administration (FDA) testing found Clostridium botulinum in finished products and in whole milk powder from a supplier, with genetic matches between samples.
- As of Dec. 10, the Centers for Disease Control and Prevention (CDC) reported 51 suspected or confirmed infant botulism cases across 19 states, with California and Texas most affected; all infants were hospitalized and no deaths occurred.
- Infant botulism can cause paralysis and respiratory failure, with early symptoms including constipation and poor feeding; prompt treatment with the BabyBIG antitoxin is critical and should not wait for lab confirmation.
- The FDA urged parents to stop using recalled ByHeart products immediately and seek medical care if symptoms appear, while noting the outbreak is not expected to affect the national infant formula supply.
Federal health officials say a multistate outbreak of botulism linked to infant formula made by New York–based ByHeart may have originated from whole milk powder used in the product.
On Nov. 11, ByHeart initially pulled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack products after detecting contamination with Clostridium botulinum, a bacterium that can cause severe illness or death, particularly in infants. C. botulinum, as BrightU.AI's Enoch noted, produces botulinum toxin, one of the most potent toxins known to humans.
The decentralized engine adds that botulinum toxin can cause botulism, a serious and potentially fatal disease characterized by paralysis and respiratory failure. The bacterium thrives in low-oxygen environments and is commonly found in soil and improperly processed foods.
A Food and Drug Administration (FDA) investigation found that two samples of those products have tested positive for the bacterium. One was a sealed sample of ByHeart powdered infant formula that genetically matched a clinical isolate taken from an infant affected in the outbreak. The second was a sample of whole milk powder collected by the FDA at a supplier used by ByHeart.
The Centers for Disease Control and Prevention (CDC) also revealed in an official statement released on Jan. 23 that ByHeart publicly reported in December that six out of 36 finished-product samples tested positive for C. botulinum. Those samples came from two production batches, 251261P2 and 251131P2, both of which were included in the initial recall.
"C. botulinum found in the sample of whole milk powder is a genetic match to the C. botulinum detected in the finished product sample of ByHeart's infant formula, according to analysis conducted by ByHeart," the CDC said.
In line with this, the CDC said further findings will be released as testing continues.
"Sample analysis is ongoing, and additional results will be reported as they become available. The detection of C. botulinum in infant formula, or its ingredients, is complex and confirmation of results can take several weeks," the agency added.
FDA and CDC warn the public about early symptoms of infant botulism
As of Dec. 10, CDC data revealed that a total of 51 suspected or confirmed cases of infant botulism have been reported across 19 states, with California and Texas reporting the highest numbers. Minnesota and Oregon have also reported significant case counts. All affected infants were hospitalized and treated, and no deaths were reported. The CDC said no new cases have been identified since that time.
The FDA said that this ongoing multi-state botulism outbreak tied to recalled ByHeart infant formula is the first documented case in the U.S. linked to contaminated infant formula.
An April 2024 report from the CDC explains that infant botulism occurs when spores of C. botulinum are swallowed and temporarily colonize an infant's large intestine, where they produce a dangerous neurotoxin. The toxin interferes with nerve function and can lead to paralysis if untreated.
Once doctors determine that an infant has botulism, treatment must begin as quickly as possible with BabyBIG, an antitoxin specifically designed for infants. The CDC has emphasized that treatment should not be delayed while awaiting laboratory confirmation.
In turn, the FDA warned that infant botulism can present with subtle early symptoms that may worsen over time. Affected infants often initially develop constipation, poor feeding, difficulty swallowing and loss of head control. In more severe cases, the illness can progress to breathing difficulties and respiratory arrest. Symptoms may take several weeks to appear after a baby ingests contaminated formula.
The FDA urged parents and caregivers to stop using the recalled ByHeart products "immediately." The agency advised those whose children consumed the formula and are showing symptoms to seek urgent medical care. Parents of infants who consumed the product but are not currently symptomatic were told to continue monitoring their children closely and seek medical attention if symptoms emerge.
Despite the seriousness of the outbreak, the FDA said it is not expected to disrupt the nation's infant formula supply. ByHeart products account for roughly 1% of all infant formula sold in the United States.
Watch Celeste Solum warning of how synthetic biology on common foodborne pathogens like C. botulinum affects food preservation in this clip.
This video is from the Celestial Report-Celeste Solum channel on Brighteon.com.
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