LittleOak infant formulas are being recalled because they have not undergone the necessary Food and Drug Administration (FDA) review for safety and quality.
The FDA issued an alert to parents and caregivers urging them not to use LittleOak Natural Goat Milk Infant Formula or LittleOak Natural Goat Milk Follow-on Formula, which are sold online.
In addition to not undergoing the required FDA premarket review, the products’ preparation instructions on the label do not align with measurements commonly displayed on infant formula bottles in the U.S., according to the FDA. This could lead to errors causing formula to be either too diluted or over-concentrated, both of which could cause serious health issues. Caregivers should not use other ways to measure the formula because these could cause contamination.
In 2022, LittleOak Company requested permission to sell infant formula in the U.S. but the FDA deferred consideration due to questions about the preparation instructions and the safety of two ingredients. No illnesses have been reported to the FDA.