Locke Lord QuickStudy: How to Handle FDA Recalls

    Locke Lord Publications

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    What is a recall?

    Recalls are among the most stressful events an FDA regulated industry will face. This paper will provide a road map from the beginning to the end of this complex process.

    A recall is undertaken when a product is found to be defective, and the only option is to remove it from the stream of commerce. Most recalls are done voluntarily by companies. In the most serious situations, FDA will request that a company initiate a recall.

    Recalls are triggered in several different ways. A customer complaint often triggers a recall. On many occasions, the company identifies the problem in the course of testing its own product. In some cases, an observation made by FDA can bring about a recall.

    Preparing for a Recall

    When one of the incidents discussed above causes a company to initiate a recall, there are several steps it must take at the outset. The first thing to take into consideration is that there is a short time between the discovery of the problem and FDA’s expectations of notification of the recall. This is especially true in the case of a recall that involves a risk to health, safety or life.

    The first step is to begin preparing a strategy. It is highly advisable for companies to have a complete recall plan in advance. Either way, there are some basis steps that must be taken immediately:

    • Identify the cause and how it was discovered
    • Identify the potential consequences in detail through a hazard analysis
    • Note any actual incidences of harm
    • Assemble a list of affected customers
    • To the extent possible at this early stage, prepare a list of affected lot numbers

    Notifying FDA

    Once you have assembled the information noted above, the next step is to contact FDA. This is done by means of a telephone call or to the recall coordinator of the FDA District Office that has jurisdiction over the location of the problem.

    FDA will want a recall submission addressing the information noted above, and may ask for more. It is important that the person designated be very familiar with the situation. If you don’t know the answer to a question, don’t guess. “I don’t know, but I will find out” is an acceptable answer at this stage.

    Communicating the Recall

    This step is critical. What is said in communications to the public and to customers has an effect on the company’s goodwill. Accordingly, it is advisable to get advice from internal or external counsel before submitting a final draft of the FDA requirement that the company issue a notice or a press release announcing the recall. You should stick to the most relevant facts and details, such as lot numbers and conclude with a paragraph reassuring customers and consumers that we are committed to taking immediate action. The notice then needs to be shared with the FDA Recall Coordinator.

    The following information should be included in the recall notice:

    • A description of the product, including lot numbers and UPC codes
    • The reason for the recall
    • An indication of whether the recall involves wholesale customers, retail customers and/or consumers
    • Whether distribution of the product must stop
    • What to do with the products subject to the recall
    • Include a response letter so customers can acknowledge receipt and compliance

    After communicating with customers, it is critical that you maintain meticulous records through the closeout of the recall. This includes who responded to the notice, how you will follow-up with those who have not yet responded, the status of the product. If you are in doubt, keep the records. Some companies prefer to maintain this information through the use of spreadsheets.

    Managing the process through FDA’s termination of the recall is a highly labor intensive process. Somebody must be designated as head of the recall team to ensure that everything goes according to plan. FDA will expect status reports and effectiveness confirmation throughout the life of the recall.

    The End of the Recall

    A recall ends, quite simply, when FDA says it does. That is why it is important to maintain close touch with the Recall Coordinator to make sure they are satisfied with your continuing actions toward administration of the recall.

    Best Practices

    There are several best practices that should be observed throughout the course of the recall:

    Have a written recall policy and designate an internal recall team

    Maintain up to date information regarding your inventory

    Keep upper management informed

    Stay in regular touch with customers

    Maintain close contact with FDA

    Document everything—don’t guess

    Develop with FDA a plan for disposal of the product

    Don’t go it alone—involve in-house and outside counsel at the outset, before speaking with FDA


    A recall is never welcome. While you cannot eliminate the stress of the event, the suggestions in this paper will help alleviate the stress and ensure that both FDA and your customers are satisfied with your conduct of the recall.

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