Baby formula maker ByHeart is recalling all of its products amid an outbreak of infant botulism likely tied to its powdered formula.

Since August, 15 cases have been reported across 12 states , nearly all among babies between 16 days and around 5 months old, according to the Food and Drug Administration.

After the FDA announced Saturday that it was investigating the outbreak and its link to ByHeart's organic Whole Nutrition Infant Formula, the company recalled two lots of the product. ByHeart then expanded the recall Tuesday to include all batches of the formula, both in cans and "anywhere packs" — small, sealed pouches.

"The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority,” ByHeart's co-founder and president, Mia Funt, said in

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