ByHeart is expanding its voluntary recall of infant formula to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack nationwide. The formula has been linked to an outbreak of infant botulism.
The California Department of Public Health has tested ByHeart formula from patient homes and found contamination with botulism that matches the bacteria from a patient.
ByHeart is now recalling pouches in additions to cans of powdered infant formula.
There are 15 patients in the outbreak so far. The patients are spread across 12 states.
The FDA and CDC have been conducting a broader investigation into a spike of 84 infant botulism cases that started in August.
While the FDA is awaiting confirmed results of its testing, ByHeart is:
Recalling all product from the market while the FDA’s comprehensive investigation seeks to identify a root cause of the broader outbreak
Testing every batch of formula with an independent third-party laboratory
Providing FDA and the California Department of Public Health full access to its facilities and unopened cans of formula to conduct testing without restriction
Sharing results from both regulatory and independent testing publicly as they become available
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.
Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack pouches should immediately discontinue use and dispose of the product.
If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately.
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