The FDA is alerting parents and caregivers about two varieties of LittleOak infant formulas that the company is currently recalling.
The products have been sold in the United States illegally because the company has not submitted the required premarket notification to the Food and Drug Administration.
Products included in this alert are:
- LittleOak Natural Goat Milk Infant Formula
- LittleOak Natural Goat Milk Follow-on Formula
The products were sold online through the company’s webpage.
Premarket notifications for new infant formula are intended to demonstrate the safety and nutritional adequacy of the formula by providing the FDA the opportunity to review key information about ingredients in the product, key nutritional information, and manufacturing information, among other things, before the product is available long-term on the U.S. market.
Additionally, preparation instructions on the labels of the recalled containers do not align with measurements commonly displayed on infant formula bottles in the United States. These directions may challenge caregivers, impeding their ability to mix the formula at the appropriate concentration properly.
Errors in mixing the infant formula could lead to diluting the formula and failing to supply the infant with adequate nutrition, which may slow or delay growth; or over-concentrating the formula, which could lead to dehydration, electrolyte imbalance, and kidney issues.
The FDA does not recommend that caregivers use other ways to measure infant formula, such as measuring cups or spoons, which could introduce microbial contaminants, such as Cronobacter sakazakii, to the product.
Parents and caregivers of infants who have purchased these products should understand that they have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. For example, the formulas contain some ingredients that the FDA has not yet evaluated to determine if they are safe for infant formula.
Suppose parents and caregivers are looking for an alternative goat milk infant formula for sale in the United States. In that case, goat milk infant formulas are currently being marketed under the FDA’s enforcement discretion policy.
Currently, the agency is unaware of any illnesses or complaints related to the LittleOak products.
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