Baby formula maker ByHeart on Tuesday recalled all of its organic Whole Nutrition Infant Formula amid a Food and Drug Administration investigation into a botulism outbreak among babies in a dozen states. File Photo by Sanjasy/Pixabay
A botulism outbreak tied to its powder baby formula prompted ByHeart to recall all of its infant formula products nationwide on Tuesday.
The recall comes after a total of 15 cases of botulism were reported in a dozen states and mostly among infants between 16 days and 5months of age, the Food and Drug Administration announced.
The FDA on Saturday said it was investigating a potential link between the botulism outbreak and ByHeart’s organic Whole Nutrition Infant Formula.
ByHeart officials said none of its unopened baby formula products have tested positive for botulism, but they are being proactive to ensure safety and consumer confidence in its products.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” ByHeart President Mia Funt said Tuesday in a company announcement.
“This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information,” Funt said. “Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.”
ByHeart officials have recalled all of its products pending the outcome of the FDA investigation and have contracted with a third party to test every batch of its infant formula.
The company also has given full access to its facilities and unopened cans of formula to the FDA and the California Department of Public Health for testing.
ByHeart also is publicly sharing the results of government and third-party testing of its products to keep consumers informed as results are made available.
The FDA and the Centers for Disease Control and Prevention also are investigating 84 infant botulism cases that started in August but weren’t reported until Friday.
Infant botulism is a rare illness that occurs when Clostridium botulinum spores are ingested and multiply in the digestive tracts of babies.
Symptoms of botulism in infected infants include constipation, a drooping eyelid, sluggish pupils, loss of appetite, breathing trouble, trouble with suckling and swallowing, reduced muscle tone, weakened crying and general weakness.
