FDA does not have authority to mandate a recall of a human drug, but it can take more authoritative legal actions against manufacturers that persist in marketing a defective product, such as seizure and injunction. A recall is a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers, and against which FDA would otherwise initiate more powerful legal action (see 21 CFR 7.40(c); also see chapter 7 in FDA's Investigations Operations Manual). Thus, manufacturers typically initiate voluntary recalls when a defect is found within a marketed batch to avoid a potentially more significant enforcement action by FDA.
