The requirements of this subpart apply:
When the Food and Drug Administration has determined that it is necessary to remove from the market a distributed infant formula that is in violation of the laws and regulations administered by the Food and Drug Administration and that poses a risk to human health; or
When a manufacturer has determined that it is necessary to remove from the market a distributed infant formula that:
Is no longer subject to the manufacturer's control;
Is in violation of the laws and regulations administered by the Food and Drug Administration and against which the agency could initiate legal or regulatory action; and
Does not present a human risk.
The Food and Drug Administration will monitor continually the recall action and will take appropriate actions to ensure that the violative infant formula is removed from the market.
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