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FDA Issues Urgent Baby Formula Warning Over Illness in 10 States

BAD BATCH

Cases of infant botulism tied to two batches of ByHeart infant formula have been reported in Arizona, California, Texas and Minnesota, among others.

HHS Secretary Robert F. Kennedy Jr., speaks at an event at the USDA Whitten Building on Monday, August 4, 2025.
Tom Williams/CQ-Roll Call, Inc via Getty Images

Federal and state health authorities are investigating 13 confirmed infant botulism cases across 10 states connected to a recalled baby-formula brand. The Food and Drug Administration says all affected infants consumed the same two lot numbers of the product, manufactured by ByHeart Inc, which was voluntarily pulled from shelves. The states hit include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. There are no deaths reported so far, and ByHeart, which accounts for only 1 percent of national formula sales, said the recall is precautionary. Under Robert F. Kennedy Jr., the Department of Health and Human Services has nevertheless launched a major review of infant-formula safety and nutrition standards. Named “Operation Stork Speed,” the effort largely focuses on testing for heavy metals and other contaminants, even as critics say the department has overstated the risks and may prompt unfounded distrust among parents toward existing, FDA-approved infant formulas. The agency’s investigation into the current outbreak remains ongoing.

Read it at CBS News

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