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A recall notice must state the approximate number of product units covered by the recall, including all product units manufactured, imported, and/or distributed in commerce. (2) The type of hazard or risk, including, by way of example only, burn, fall, choking, laceration, entrapment, and/or death.

Recent Class 3 Drug Recalls XR: The brand name for hydrochloride, used to treat Alzheimer's and other cognitive disorders. : A prescription medicine for treating edema in patients with congestive heart failure, renal disease, and cirrhosis of the liver.

FDA's role in a recall is to oversee a company's strategy, assess the adequacy of the recall and classify the recall. Class I: A dangerous or defective product that could cause serious health problems or death. Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.

The FDA will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report.

Inspectors will conduct recall audit checks (RACS) to monitor a recalling firm's removal of recalled products from distribution channels and to assist FDA in refining lists of retail level stores that may have sold products subject to recall.

Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Recalls are assigned subjective levels of risk by the reporting agency and may be reported using the following classes listed below. There are three classes of recall used by the FDA and USDA: Class 1, Class 2 and Class 3, often represented with Roman numerals I, II and III respectively.