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Recalls - Background

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Transparency Report Arrow Background

Summary of Public Comments

Considerations

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Background

When an FDA-regulated product is defective, potentially harmful, or mislabeled, recalling that product—removing it from the market or correcting the problem—is often the most effective means for protecting the public from products that violate the laws administered by FDA. 

Generally, FDA does not have mandatory recall authority (i.e., the authority to order a manufacturer and/or distributor to recall a product), except under limited circumstances related to certain devices, biological products, human tissue intended for transplantation, and infant formula. 

A firm may initiate a recall at any time.  With the exception of recalls ordered under FDA's mandatory recall authority or pursuant to a court order, a recall is a voluntary action that takes place because manufacturers and/or distributors carry out their responsibility to protect the public from products that present a risk of injury or gross deception, or are otherwise defective.  A recall may also follow notification of a problem by FDA or a state agency.  In certain urgent situations, FDA may formally request a recall.  If a manufacturer does not recall a violative product, or if a firm-initiated recall proves inadequate, FDA can seek relief in court that requires the company to correct the violations and/or destroy the violative product. 

FDA has issued guidance on recalls in 21 C.F.R. Part 7 which provides FDA's policy and procedures and industry responsibilities.  An additional document titled “Guidance for Industry: Product Recalls, Including Removals and Corrections” is also available on FDA's Web site.  It provides guidance both in the conduct of recalls and in the information needed by FDA to classify, monitor, and assess the effectiveness of a recall.

FDA requests that if a firm is removing or correcting a distributed product because the firm believes the product to be in violation of the statutes or regulations administered by FDA, that the recalling firm provide certain information to the agency.  This requested information includes the identity of the product that is the subject of the recall, the reason for the recall, an evaluation of the risk, the volume of the product, the distribution of the product, and the firm’s strategy for the recall. 

As specified in FDA's Regulatory Procedures Manual, FDA reviews the information provided, assesses the health hazard presented by the product that is the subject of the recall, and classifies the recall as a Class I, Class II, or Class III recall.  Recalls are classified according to the level of health hazard involved:

  • Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause adverse health consequences or death.  Examples could include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
  • Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.  An example could include drugs that are under-strength but not used to treat life-threatening conditions.
  • Class III is a situation in which use of, or exposure to, a violative product is not likely to cause any adverse health consequences, but the product violates FDA labeling or manufacturing laws.  Examples could include a minor container defect, or a lack of English labeling on a retail food.

After classifying a recall, FDA includes information about the recall in the FDA Enforcement Report, which is available on FDA’s Web site.  The time that it takes for FDA to classify a recall upon receipt of information from a recalling firm impacts the timing of FDA's communications to the public about the recall. 

In addition, FDA immediately posts on its Web site press releases related to recalls.  Most often these press releases are issued by recalling firms.  FDA also posts on its Web site press releases issued by state agencies.  FDA may also issue a press release and post that on its Web site if the Agency believes that there is a recall of a product likely to have a serious public health consequence and the recalling firm has not issued a press release or other public statement.

FDA monitors the firm’s implementation of the recall to ensure that it has been effective and determines when the recall action should be terminated.  A recall is considered terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy and when it is reasonable to assume that the recalled product has been recovered, corrected, reconditioned, or destroyed.  FDA issues a written notification that a recall is terminated to the recalling firm, but does not notify the public when a recall has been terminated.