Baby formula linked to infant botulism cases in Oregon and nine other states is being recalled after federal authorities said the bacteria that produces the toxin was found in the formula.
In separate statements on Nov. 8, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said two lots of ByHeart Whole Nutrition Infant Formula were recalled.
The California Department of Public Health noticed the increase in infant botulism cases in babies who drank ByHeart powdered infant formula and alerted the CDC. The agency also tested an open can that was fed to a baby with botulism and preliminary results indicated the presence of the bacteria that produce botulinum toxin.
Testing of leftover formula is underway, the FDA said. Results are expected in the coming weeks.
ByHeart agreed to a voluntary recall of the two lots, but denied the validity of the test that found the toxin and said it was conducting its own additional testing.
The formula was distributed online and nationwide, according to the FDA. The recalled formula makes up less than 1% of all infant formula sold in the United States and does not raise shortage concerns, the agency said.
All 13 cases have resulted in hospitalizations, according to the CDC. No deaths were reported as of Nov. 10. One case has been reported in Oregon.
What ByHeart products are being recalled?
Two lots of ByHeart’s Whole Nutrition Infant Formula are being recalled:
Lot: 206VABP/251261P2 with a “use by
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