Botulism cases in infants rise to 31 amid ongoing recall of ByHeart baby formula, FDA says
The number of reported cases of botulism linked to ByHeart baby formula has doubled following the company’s expansion of its product recall earlier this month, as reported by the U.S. Food and Drug Administration.
As of now, there have been a total of 31 reported cases of infant botulism associated with various lots of ByHeart Whole Nutrition infant formula. These cases have resulted in hospitalizations across 15 states since August 9, with the most recent case reported on November 13. Fortunately, there have been no reported deaths.
Symptoms of infant botulism can take weeks to manifest and may include poor feeding, loss of head control, drooping eyelids, and a flat facial expression. Affected babies may exhibit weakness and have difficulty swallowing or breathing, according to the Centers for Disease Control and Prevention.
Despite the expanded recall of all ByHeart infant formula products, the FDA has received reports indicating that the recalled formula is still available on store shelves in multiple states.
The FDA has also warned that the recalled products have been sold online and shipped internationally, advising consumers to avoid using any ByHeart brand products.
“We are dedicated to supporting parents during this challenging time,” ByHeart stated on November 13. “We are actively working on updates and will continue to provide information promptly and clearly.”
Parents of affected infants have initiated legal action against ByHeart, alleging that the formula was defective and that the company was negligent in its distribution. The lawsuits seek compensation for medical expenses, emotional distress, and other damages.
Hanna Everett, a parent of one of the affected infants, described the ordeal as “absolutely terrifying” in an interview with CBS News. ByHeart has pledged to address any legal claims in due course.
Infant botulism is caused by a bacterium that produces toxins in the large intestine. The CDC warns that this bacterium can lead to serious illness, including paralysis.
The FDA has disclosed that health officials in various states have collected samples of leftover formula for testing. Additionally, unopened product samples are being tested as part of the agency’s investigation. Results are expected in the coming weeks.
