Though the FDA is empowered to order recall of any drug or health supplement, more often than not it is the drug and pharma companies that themselves initiate a recall.
Why do they do it, when it obviously causes them financial harm, and in many cases damage to their goodwill and reputation? In fact many a times, manufacturers initiate what is known as a market withdrawal. This may be on account of something as minor as package tampering which in no way impacts either the efficacy or the safety of the drug or supplement in question. In such cases the product has not even fallen foul of the FDA guidelines. The ostensible reason for such recalls is public concern about the safety of the product in question.
So rather than face growing public outrage about what is after all a minor glitch, the manufacturer considers it prudent to recall the product. As a matter of fact there has been a marked increase in the overall incidence of drug recalls of late. This is borne out by this interesting statistic. According to FDI 2009 saw 1742 cases of drug recalls, a 309% increase over the 426 in 2008. A great many of these were voluntary.
What usually happens is that the FDI may point out an issue with a particular product and formally request a manufacturer to issue a recall. In most cases the manufacturers will initiate a voluntary drug recall rather than have the FDA pursue a regulatory course of action like a seizure or an injunction against the product. When issuing a recall the manufacturer categorizes it as one of the following 3 levels- level 1 where the product in question is in all likelihood harmful and its consumption may cause serious illness or even death; level 2 where the consumption of the drug may cause temporary or reversible health concerns, but certainly no long term and permanent damage or death and lastly level three where the product in question will have no harmful consequences for the person consuming it.
In the case of voluntary recall there are further three categories known as depths assigned. One is at the consumer or user level and the recall impacts patients and physicians. The second recall is at the retail level and it impacts retail and hospital pharmacies. The last is wholesale recall that includes distribution levels within the manufacturing and wholesale levels.
Thus we see that voluntary drug recall is a pre-emptive measure designed to either contain a minor situation or a major salvage operation designed to prevent the outbreak of a major and costly controversy that has the potential to derail a company or a brand name. Both the FDA and manufacturers play their parts with the former acting as a conscientious watchdog and the latter as responsible and responsive corporate citizens who care for health and well being of the general public who also happen to be their customers. The whole system is in a sense a self corrective one and in the end it is the consumer who benefits more than anybody else.