You may remember the baby formula shortage that occurred early in 2022. If you were a new parent or caregiver, this was an especially stressful time, especially after heartaches we all felt from pandemic and other shortages the United States faced. A New Zealand based company started shipping their baby formula to help with the shortage, and now they are the focus of the latest recall by the U.S. Food and Drug Administration.

The FDA has issued a voluntary recall of of LittleOak infant formulas that were illegally sold in the U.S. The reason for the recall is "because the company has not submitted to the FDA the required premarket notification."

FDA.gov

What does that reasoning mean? According to FDA.gov, premarket notifications are meant to test safety and nutritional value for the product. Giving the FDA a chance to review ingredients, nutritional value, manufacturing practices, etc. If a product passes these tests, they are allowed to hit the store shelves.

"It is prohibited to introduce into U.S. commerce a new infant formula without submitting a premarket notification to the FDA." - FDA.gov

As of this writing, there has been no health issues reported due to the formula, but the FDA does warn that preparation instructions on the labels don't align with the standard instructions that is common with other infant formulas in the U.S.

Improper mixing of the formula could cause dehydration, electrolyte imbalance, kidney issues, malnutrition, and slow or delayed growth.

The LittleOak Company has posted to their website about this warning from the FDA. The company is in the process of FDA approval with their formulas, and they insist that it is not a nutritional issue, but a labeling issues that has caused the recall.

"We have agreed with the FDA and will focus our full efforts to obtain FDA approval of our infant formulas as quickly as we can, so we can make our products available again to US families as soon as possible." - The LittleOak Company

 

For more information on this recall, you can visit FDA.gov.

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