The FDA is warning parents and caregivers about a recall for LittleOak Infant Formula and Follow-On Formula made with Natural Goat Milk.
The formula is manufactured in New Zealand, but parents in the U.S. started buying it during a massive infant formula shortage that was triggered by several recalls last year.
According to the FDA, LittleOak infant formula was sold in the U.S. illegally because the company has not submitted a mandatory pre-market notification to the FDA.
Because the manufacturer did not submit a pre-market notification, safety officials have not verified the safety and nutritional adequacy of the formula, among other things.
Another problem is that the preparation instructions are in metric measurements, which could be confusing for some parents the U.S., and lead to over-concentrating or under-concentrating the formula.
According to the FDA warning:
“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 instructions also recommend using cups or spoons to measure the formula, which the FDA warns is dangerous because it could introduce disease-causing microbes, such as Cronobacter sakazakii bacteria.
LittleOak recalled the infant formula on September 9, 2023.
The company said it plans to soon begin manufacturing FDA-compliant LittleOak Toddler Milk (Stage 3) in the U.S., which they said will become available “in the coming months.”