Nutricia, a unit of the French diary giant Danone, said the nationwide recall affects only one lot of the hypoallergenic formula Neocate, which entered the market during the first ten days of this month.
The voluntary recall follows a “one time blending error”, which resulted in lower protein levels that those declared on the label.
“This limited formulation concern does not present any immediate risks of injury or other adverse health consequences. No adverse events have been reported as a result of this issue,” said the US Food and Drug Administration in a statement on Tuesday.
Neocate is not intended for general use. The product is usually given to infants in the care of health professionals.