What is the FDAs Role in Drug Recalls?


Although the US Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (1938) to "order" a recall or confiscate a product, it very rarely does so. Over the years, a cooperative effort between the FDA and the industries it regulates has been shown to be a quick and reliable approach to removing unsafe products from the market. After all, it is in the interest of both to get dangerous products out of consumers' hands as soon as possible.

I some cases, a manufacturer discovers that one of its products is unacceptably dangerous and recalls it on its own. In other cases, the FDA will share its findings with a manufacturer that a drug is more dangerous than previously thought, and may suggest or request a recall if it deems that the drug's benefits no longer outweigh its risks. In all but one case, drug manufacturers have complied. The manufacturer then keeps the FDA updated on the status of any drugs remaining on the market.

A drug recall for a drug the FDA previously certified can bring bad publicity to the agency. In part for this reason, the FDA often refrains from issuing "safety-based" recalls. If a drug continues to have a place in treatment, the FDA will instead usually work with doctors and pharmaceutical companies to change warning labels.

When a drug is recalled, however, the FDA categorizes the recall into one of three classes according to the level a hazard involved:

  • Class I recalls - this is the most severe type of recall. They are issued for defective or dangerous products with a potential for serious injury or death.
  • Class II recalls - these are issued for products with a lower chance of causing major health problems or death, but could also cause temporary health problems.
  • Class III recalls - these are reserved for products unlikely to cause adverse health consequences, but violate manufacturing regulations or FDA labeling recommendations (or now mandates).

Depending on the class of recall, the FDA will follow up on how the company executes it. For a Class I recall, the FDA ensures that all drugs are removed to the extent possible. Conversely, in a Class III recall, the FDA may only spot check to satisfy itself that the product has been removed.

The drug manufacturer may issue a press release as part of its effort to recall a medication. The FDA, on the other hand, will seek publicity about a recall only when it deems necessary for the public to be alerted about a serious hazard.