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Food and Drug Administration
Recall Procedures

By Deema Tarazi, JD, Staff

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 also be confusing! The Food and Drug Administration (FDA) follows several different recall procedures,
outlined in its Regulatory Process Manual.

First, what is a recall? A recall is an action taken by a manufacturer to remove a product from the market. A recall may be voluntary
by the manufacturer. Or a recall may be initiated by a request from the FDA, or by an FDA order pursuant to its authority under
federal statute, also known as a mandatory recall.

Here are the different recall classifications.1

CLASS OF RECALLS

Class I There is a reasonable probability that the use of, or exposure to, a violative product
will cause serious adverse health consequences or death.

Class II Use of, or exposure to, a violative product may cause temporary or medically-
reversible adverse health consequences, or the probability of serious adverse
health consequences is remote.

Class III Use of, or exposure to, a violative product is not likely cause adverse health
consequences.

Market When a product has a minor violation that would not be subject to FDA legal action.
withdrawal

Medical device When a medical device may present an unreasonable risk of substantial harm.
safety alert In some cases, these situations may also be considered recalls.

Voluntary Recall: Initiation of a Recall by a Once the sub-accounts are informed about the recall, the sub-
Manufacturer accounts must promptly follow the recall strategy that was pre-
A manufacturer may decide to voluntarily initiate a recall viously put in place for that account.
at any time to fulfill their responsibility to protect the public
health from products that present a risk of injury or gross de- FDA Requested Recall
ception, or are otherwise defective.2 If a recall is manufactur- In urgent situations, the FDA may request a recall.6 The request
er-initiated, the FDA reviews the information provided by the is directed to the manufacturer that has primary responsibility
manufacturer, conducts a health hazard evaluation, classifies for making or marketing the product. These recalls fall most of-
the recall, and then advises the manufacturer in writing of the ten into the Class I category. Before the FDA formally requests
assigned recall classification.3 The FDA then places notice of such a recall, the agency has usually collected evidence suffi-
the recall in the weekly FDA Enforcement Report. Almost all cient to support legal action.
recalls implemented in the US are begun on a voluntary basis
by the manufacturer.4 The Associate Commissioner for Regulatory Affairs approves
all recall requests from the FDA. After an Alert is submitted,
If a manufacturer has voluntarily initiated a recall, it is their the recall is recommended to the Recall Enterprise System
responsibility to promptly notify each of its direct accounts. If (RES).7 The RES is an electronic data system used by the FDA
the recall extends beyond the direct accounts, then the direct to submit, update, classify, and terminate recalls.8 The manu-
accounts should be instructed by the recalling manufacturer facturer is then notified via letter specifying the violations and
to contact sub-accounts that may have received the product.5 health hazards involved, and recommending a recall strategy
to ensure an effective recall of the product.9
10 Dateline Federation | Summer 2017