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FDA closes investigation into Listeria outbreak; continues work on infant botulism outbreak

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The Food and Drug Administration has closed an investigation into an outbreak of Listeria infections without finding a source of the pathogen.

The agency first posted the outbreak on Sept. 17. Eight patients were confirmed in the outbreak, but the FDA did not report where they live, their ages or whether any of them required hospitalization or died.

The FDA initiated traceback during its investigation, but did not reveal what food was being traced. Similarly, the agency conducted an onsite inspection and sample testing but did not reveal what location was inspected or what was tested.

In other outbreak news, an outbreak of infant botulism traced to ByHeart powdered formula continues. As of this week, there are 15 confirmed patients spread across 12 states. However, the company was notified that there have been 84 cases of infant botulism since August.

ByHeart has recalled all of its powdered infant formula. The California Department of Public Health found the same strain of botulism that is making babies sick in a sample of ByHeart formula collected from a patient’s home.

Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possible respiratory arrest. If your child is experiencing any of these symptoms, please seek medical attention immediately.

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Source: https://www.foodsafetynews.com/2025/11/fda-closes-investigation-into-listeria-outbreak-continues-work-on-infant-botulism-outbreak/


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