Understanding FDA Recalls: What to Do if You’ve Received a Voluntary or Mandatory Notice

Find Out What You Need to Know if You’ve Received a Voluntary or Mandatory Recall Notice from the FDA

Recalls can prove incredibly costly for manufacturers and other companies. Not only does instituting a recall mean taking products off of distributors’ and retailers’ shelves, but it also presents a high risk for litigation. The U.S. Food and Drug Administration (FDA) will not hesitate to pursue enforcement action if it determines that additional corrective (or punitive) measures are necessary, and recalls frequently spawn large-scale multi-district or class action lawsuits.

As a result, if your company has received a recall notice from the FDA, you need to proceed very carefully. Even if a recall isn’t warranted, your company must be prepared to demonstrate why this is the case, and there may still be steps your company needs to take to mitigate its risk exposure. If a recall is warranted, then working quickly will be essential, as unnecessary delays can lead to unnecessary consequences.

Voluntary vs. Mandatory: Understanding Companies’ Rights and Obligations

Upon receiving a recall notice from the FDA, one of the first steps to take is to determine whether the recall notice is voluntary or mandatory. Most FDA recall notices are voluntary. In fact, the FDA describes a recall as, “a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.”

With that said, the FDA has the authority to issue mandatory recall notices in some cases, although this authority does not extend to all classes of FDA-regulated products. In most cases, the FDA will only issue a mandatory recall notice after a company has failed to conduct an adequate voluntary recall—and, even then, only if the device or other product at issue poses a “reasonable probability . . . [of] serious, adverse health consequences or death.”

Thus, while all FDA recall notices require prompt action, mandatory recall notices present even greater risks. It is worth noting, however, that even if the FDA chooses not to issue a mandatory recall notice (or does not have the authority to issue a mandatory recall notice with respect to a particular product), it can still pursue enforcement through other means. If a company fails to conduct an adequate voluntary recall for a dangerous device or other product, not only can the company continue to face increasing civil liability exposure, but it may face FDA-imposed injunctions, fines, and other penalties as well.

In short, if your company has received a recall notice from the FDA—regardless of whether the notice is voluntary or mandatory—you must act quickly to determine your company’s next steps.

FDA Class I, II, and III Recalls: Understanding the Differences and Their Implications

All FDA recall notices—both voluntary and mandatory—fall into one of three “Classes” (although, as a practical matter, mandatory recalls will generally fall into Class I). The “Class” of a recall plays a key role in determining both a company’s potential liability exposure and the steps a company needs to take in response to its recall notice from the FDA. The three “Classes” of FDA recalls are:

• Class I – Class I recalls involve “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” This could be a failure to list a major allergen in a food product, for example.
• Class II – Class II recalls involve “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.” This may include foodborne illness from food products.
• Class III – Class III recalls involve “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

With all three “Classes,” companies have the right to object if they disagree with the FDA’s determination that a recall is necessary. Generally, this should begin as an interactive and collaborative process, with the company’s outside counsel seeking to engage proactively with FDA staff to understand their concerns and address any oversights or misconceptions of potential health risks. If a recall is unnecessary, taking this approach will generally afford the most favorable and cost-effective outcome. Depending on the circumstances, this may involve keeping the product on the market, or it may involve pursuing an alternative course of action—such as executing a correction or market withdrawal, or issuing a safety alert—that has less-significant legal and commercial implications.

If the FDA is not willing to agree to an alternative course of action, then litigation may be the most prudent path forward. Along with significant experience working with the FDA to resolve recall-related issues and other compliance concerns, our team also has significant experience litigating to protect our clients’ interests when necessary.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

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Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

5 Steps to Take After Receiving a Recall Notice from the FDA

With these considerations in mind, there are some important steps that all companies should take after receiving a recall notice from the FDA. These steps include (but are not limited to):

1. Review the Recall Notice in Detail

The first step is to review the recall notice in detail. It will contain key information about the recall, including whether the recall is voluntary or mandatory and the FDA’s recall “Class” designation. It should also specify the reason for the FDA’s recall request and identify the specific products involved.

2. Independently Assess Whether a Recall Is Necessary

After receiving a recall notice from the FDA, the recipient should independently assess whether a recall is necessary. If a recall isn’t necessary, then the next step will be to communicate with the FDA in an effort to work out an alternate resolution. However, if a recall is necessary, then the recipient’s next steps should be focused on executing an appropriate recall as efficiently as possible.

3. Develop a Recall Strategy (or Other Appropriate Course of Action)

When conducting a recall, the FDA advises that, “[t]he recalling firm should develop a recall strategy that takes into account the following factors as they apply to the individual circumstances of the particular recall:

• “Results of health hazard evaluation.
• “Ease in identifying the product.
• “Degree to which the product’s deficiency is obvious to the consumer or user.
• “Degree to which the product remains unused in the marketplace.
• “Continued availability of essential products.”

This recall strategy must be submitted for the FDA’s review, though the FDA makes clear that the recipient of a recall notice, “need not delay initiation of a recall pending review of its recall strategy.”

4. Communicate Effectively with the FDA

When dealing with a recall notice, effective communication with the FDA is critical throughout the response process. The FDA is generally willing to work with companies that take a reasonable and good-faith approach to addressing its concerns regarding a product’s safety, health implications, or efficacy. At Oberheiden P.C., we communicate with the FDA on behalf of our clients, taking a collaborative approach while tactfully enforcing our clients’ rights and preserving all available options for seeking legal redress if necessary.

5. Take Any Necessary Steps to Minimize the Company’s Liability and Ongoing Risk Exposure

Along with executing an effective recall strategy (or taking another appropriate course of action), companies that have received recall notices from the FDA should also take any necessary steps to minimize their liability and ongoing risk exposure. Depending on the circumstances, this may involve redesigning their products or modifying their manufacturing processes, or it may require a substantial overhaul of their FDA compliance policies, procedures, and practices.

FAQs: Responding to an FDA Recall Notice

Speak with an FDA Lawyer at Oberheiden P.C. in Confidence

If your company has received a recall notice from the FDA, we encourage you to contact us promptly for more information. To speak with an FDA lawyer at Oberheiden P.C. in confidence, please call 888-680-1745 or request a complimentary consultation online today.