A company that makes organic baby formula is recalling all of its products over an infant botulism outbreak.

On Tuesday, ByHeart said it made the move after an expanding outbreak of infant botulism.

According to ABC News, company officials said they enacted the unusual recall “in close collaboration” with the U.S. Food and Drug Administration, “despite the fact that no unopened ByHeart product has tested positive” for the contamination.

The Food and Drug Administration said at least 15 babies across 12 states have “suspected or confirmed” cases of infant botulism after consuming ByHeart’s powdered infant formula. At least two of the hospitalizations occurred in Texas. No deaths have been reported.

Infant botulism can be life-threatening. The bacterial infection can lead to muscle paral

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