FDA Recall — Understanding The Process Of Patient Protection


The U.S. Food and Drug Administration (FDA) regulates pharmaceuticals and medical devices sold in the United States. The agency’s duties include:

  • Approving use of medical products and drugs
  • Issuing warnings and alerts about potential dangers
  • Recalling harmful or ineffective products from the market
  • Regulating manufacturing standards and labeling

A recall occurs when the manufacturer removes a certain drug or device from the market or corrects violations of the laws. Although the company that makes or distributes the product is responsible for the recall, the action may be initiated on the company’s own initiative, by the FDA’s request or under statutory authority.

Recalls happen more frequently than the public realizes. The FDA monitored 3,640 recalls in 2011. However, a recall does not always mean that a drug can cause you harm or should be discontinued. The FDA explains the reason for its actions in every case on its regularly updated recall list, and the agency further classifies the decision as:

  • Class I recall — There is a reasonable likelihood of serious adverse health consequences or death.
  • Class II recall — There may be temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
  • Class III recall — The product is not likely to cause adverse health consequences.
  • Market withdrawal — A minor violation that would not be subject to FDA legal action exists, and the manufacturer takes action to correct it.
  • Medical device safety alert — The medical device presents an unreasonable risk of substantial harm.

Unfortunately, a product often does not reach the recall stage until patients have been harmed.

If you discover that the medication, implant or equipment you use is on the recall list, contact your doctor immediately to learn how you can best protect your health and safety.

Topics:  FDA, Medical Devices, Prescription Drugs

Published In: Consumer Protection Updates, Personal Injury Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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