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In a new article published by ABCByHeart, a maker of organic baby formula, has recalled all its products nationwide after an outbreak of infant botulism sickened at least 15 babies in 12 states since August. All affected infants were hospitalized but no deaths have been reported. The company first recalled two batches but later expanded it to all products, including ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches, sold in major retailers like Target, Walmart, and Whole Foods. Parents are urged to stop using and throw away any ByHeart formula immediately.

The U.S. Food and Drug Administration said that ByHeart formula appears in a disproportionate number of infant botulism cases, despite making up only about 1% of formula sales in the U.S. While no unopened cans have tested positive, California health officials confirmed contamination in an open container linked to one sick baby. ByHeart said it made the decision “to protect babies above all else” and is fully cooperating with regulators.

ByHeart produces its formula in Iowa and cans it in Oregon, where FDA inspectors are currently investigating. The company is testing every batch with independent labs and sharing results with health officials. Infant botulism is rare but serious and affects babies under 1 year old when bacteria produce toxins in their intestines.

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