US EditionInfant Botulism Probe: Tainted Products May Date to 2022, FDA Says
- On Dec. 11, federal health officials said the outbreak now includes at least 51 infants across 19 states after reviewing reports dating back to late 2023, involving ByHeart Whole Nutrition formula.
- Inspection documents reveal prior contamination issues dating to 2022, including a recall of five batches for cronobacter sakazakii, a 2023 FDA warning letter, and a Reading, Pennsylvania plant shutdown after an independent laboratory found 36 samples containing botulism-causing bacteria.
- Dr. Jennifer Cope said `It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots`, and clinicians note a 30-day symptom development window including clinical symptoms of infant botulism.
- The FDA said it cannot rule out widespread contamination of all ByHeart formula products and sent inspectors last month to plants in Allerton, Iowa, and Portland, Oregon, while families have sued ByHeart in federal courts.
- ByHeart is about 1% of the U.S. market and sold about 200,000 cans monthly before its Nov. 11 recall, while the FDA warns all products may be affected.
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50-Plus Babies Sickened in Botulism Outbreak
Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022. The US Food and Drug Administration said investigators "cannot rule out the possibility that contamination might have affected all ByHeart...
MedPage Today
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(MedPage Today) -- Note that some links may require registration or subscription. The multi-state infant botulism outbreak related to ByHeart Whole Nutrition infant formula has reached 51 cases, according to an FDA alert. The World Health Organization...
Infant Botulism Outbreak Expands With More Than 50 Babies Affected
An outbreak of infant botulism tied to baby formula has expanded to include 51 infants across 19 states, federal officials said on Dec. 11. The increase was partly driven by officials starting to look at reported cases dating back to late 2023 for infants who consumed formula from ByHeart Whole Nutrition, the Food and Drug Administration and the Centers for Disease Control and Prevention said. The FDA “cannot rule out the possibility that contam…
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