Nov. 11 (UPI) -- A botulism outbreak tied to its powder baby formula prompted ByHeart to recall all of its infant formula products nationwide on Tuesday.

The recall comes after a total of 15 cases of botulism were reported in a dozen states and mostly among infants between 16 days and 5months of age, the Food and Drug Administration announced.

The FDA on Saturday said it was investigating a potential link between the botulism outbreak and ByHeart's organic Whole Nutrition Infant Formula.

ByHeart officials said none of its unopened baby formula products have tested positive for botulism, but they are being proactive to ensure safety and consumer confidence in its products.

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