Understanding FDA Drug Recall Procedures

Advocacy News
It is important to pay attention when a product is recalled, but with all the different sources of information, and the different types of recalls, it can be confusing! The Food and Drug Administration follows several different recall procedures, outlined in the Regulatory Procedures Manual.[1] Recalls are used because they have the potential to be faster and to deliver information to consumers in an expeditious manner. Recalls are to protect the public’s health.
First, what is a recall? A recall is an action taken by a manufacturer to remove a product (food, drugs, medical devices and cosmetics) from the market. A recall may be initiated by the manufacturer or initiated by request from the FDA, in either case the manufacturer removes or corrects a product that is in the market and in violation of FDA rules and regulations. In both cases, the FDA considers the recall to be manufacturer initiated. Alternatively, an FDA-mandated recall, also known as a mandatory recall, occurs when FDA orders a manufacturer to recall a product or mandates recall requirements. The FDA’s role is to oversee the manufacturer’s recall strategy, monitor the recall for effectiveness and classify the recall.
Here are the different recall classifications. [2]

  • Class I recall: Includes a health hazard situation where there is reasonable probability that the use of the product will lead to serious, adverse health consequences or death.
  • Class II recall: Includes a potential health hazard 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.
  • Class III recall: Includes a situation in which use of or exposure to the product is not likely to cause adverse health consequences.
  • Market withdrawal: When a product has a minor violation that would not be subject to FDA legal action a “market withdrawal” occurs. The product is removed by the firm from the market or corrects the violation.
  • Medical device safety alert: Released in circumstances where a medical device may present an unreasonable risk of substantial harm. These situations also are considered recalls in certain cases.

The major difference between voluntary, requested and mandatory recalls is who initiates the process. Voluntary recalls are initiated by the manufacturer of the product and it is the manufacturer’s responsibility to contact the direct accounts about the recall. FDA requested recalls are initiated by the FDA due to the potential for harm to those who use the product and based on an agency determination that action is necessary to protect the public health and welfare. Mandatory recalls are narrowly restricted by statute and the FDA can only order a manufacturer to recall if it fits within the parameters of the statute. Based upon the gravity of the situation, the FDA will issue a public warning.

Voluntary Recall: Initiation of a Recall by a Manufacturer
Consistent with its responsibility to protect the public health from products that are defective or potentially harmful, a manufacturer may voluntarily initiate a recall.[3] If a recall is manufacturer-initiated, the FDA reviews the information provided by the manufacturer, conducts a health hazard evaluation, classifies the recall, and then advises the manufacturer in writing of the assigned recall classification.[4] The FDA then places the notice of the recall in the FDA Weekly Enforcement Report.[5] Almost all recalls implemented in the U.S. are begun on a voluntary basis by the manufacturer.
If a manufacturer has voluntarily initiated a recall, it is the manufacturer’s responsibility to promptly notify each of its direct accounts. If the recall extends beyond direct accounts, then the direct accounts should be instructed by the recalling manufacturer to contact sub-accounts that may have received the product. Once the all accounts have been informed about the recall, they must promptly follow the recall strategy that was previously put in place for that account.[6]
FDA Requested Recall
In urgent situations, the FDA may request a recall. The request is directed to the manufacturer that has the primary responsibility for making or marketing the product. Class 1 category recalls are most often requested recalls. Before the FDA formally requests a recall, the agency will have collected evidence to support the action.[7] It is important to note that an FDA considers and FDA requested recall to be manufacturer initiated.
The Associate Commissioner for Regulatory Affairs approves all recall requests from the FDA. A letter outlining the need for a recall is sent to manufacturer. After a recall has begun, the recall is entered in the Recall Enterprise System.[8] The RES is a database used by the FDA to submit, update, classify and terminate recalls. [9]
FDA Mandated Recalls
The FDA’s authority to issue a mandatory recall is very limited.[10] Subjects of mandatory recalls can include: devices, biological products, human tissue intended for transplantation, infant formula, tobacco products and food.[11] The FDA also has discretion to order a mandatory recall if it finds that a human cell, tissue or cellular or tissue-based product is a source of dangerous infection to humans, or does not adequately protect against communicable disease.[12]
Elements of a Recall
Each FDA recall follows specific timelines and procedures depending upon the circumstances.[13] For example, each recall is initiated with a written order that states the violation, the product, lot and serial numbers to be recalled, and the timeline for the recall. Each recall is unique and requires its own recall strategy developed by the Center Recall Unit.[14] The CRU will consider how far the recall should extend, whether the public needs to be warned and if so, in what geographical area, and the appropriate assessment for recall effectiveness.[15]

[1] FDA Regulatory Procedures Manual, April 2019 – Chapter 7: Recall Procedures, https://www.fda.gov/media/71814/download
[2] https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4286830/, page 2. Accessed 7/28/19.
[4] https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices#3. Accessed 8/1/19.
[5] https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls. Accessed 8/1/19.
[6] FDA Regulatory Procedures Manual, April 2019 – Chapter 7: Recall Procedures, https://www.fda.gov/media/71814/download, page 11.
[7] FDA Regulatory Procedures Manual, April 2019 – Chapter 7: Recall Procedures, https://www.fda.gov/media/71814/download, page 12.
[8] FDA Regulatory Procedures Manual, April 2019 – Chapter 7: Recall Procedures, https://www.fda.gov/media/71814/download, page 13.
[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4286830/, page 5, 6.
[10] http://www.fdalawblog.net/2014/08/who-can-recall-what-fdas-mandatory-recall-authority-is-a-us-district-court-could-not/. Accessed 8/4/19.
[11] Id.
[12] Id.
[13] FDA Regulatory Procedures Manual, April 2019 – Chapter 7: Recall Procedures, https://www.fda.gov/media/71814/download, page 22
[14] Id.
[15] Id.