California-based Designed By Nature is recalling certain milk powder formulas as they are deficient in multiple nutrients required for infant formula, the U.S. Food and Drug Administration said.

The recall involves Goat’s Milk Powder, Cow’s Milk Powder and Base Milk Powder formulas with an expiration date between May 01, 2021 thru June 11, 2022. The company intends to change labeling to make it clear that these products are not intended to be used as infant formula.

In addition, these products have not been tested for the presence of Cronobacter, a pathogen that can be particularly dangerous to infants and is required testing for powdered infant formula.

However, the company has not received any reports of injury or illness to date related to the products.

The Federal Food, Drug, and Cosmetic Act or FFDCA defines infant formula as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk”. FDA regulations define infants as persons not more than 12 months old.

All infant formulas sold in the United States must meet the requirements of the Infant Formula Act (section 412 of the Food, Drug, and Cosmetic Act)

Designed by Nature said its formulas are not intended or approved for infants.

The company advised parents and caregivers of infants 12 months and younger to not use these products.

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