This cooperation between FDA and its regulated industries has proven over the years to be the quickest and most reliable method to remove potentially dangerous products from the market.
FDA guidelines for companies to follow when recalling defective products under the Agency's jurisdiction are published in Title 21 of the Code of Federal Regulations, Part 7.
The guidelines also call on manufacturers and distributors to develop contingency plans for product recalls that can be put into effect if, and when needed.
Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.
Examples might be a container defect (plastic material delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English labeling in a retail food.
In contrast, for a Class III recall, the Agency may decide that it only needs to spot check to make sure the product is off the market.