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 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 also see FDA Investigations Operations Manual, Chapter 7- Recalls, section 7.1.1.1. 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.
