Many companies discover a food safety issue that might require a recall and find themselves unsure of what to do, let alone how to engage with the U.S. Food and Drug Administration (FDA). Worse yet, they have never given much thought to the fact that such a scenario might arise.

This article walks through some of the key considerations that companies should have front-of-mind in this situation. Food safety issues and recalls often follow a familiar cadence, so this article is divided into three temporally focused sections. Section one focuses on the time before the issue arose; section two addresses discovery of the issue and response, including the need to potentially recall the product; and section three discusses the aftermath.

Before the Food Safety Issue Arises

In practice, developing the proper response to a food safety issue, including one that might necessitate a recall, starts long before the issue arises.

The Food Safety Modernization Act (FSMA) requires that companies have written food safety plans that are prepared by a qualified individual.¹ These food safety plans are designed, in keeping with FDA's Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Control regulations at 21 C.F.R. Part 117, to prevent food safety issues before they arise. A good food safety plan does this by assessing the potential hazards that might exist and then implementing preventive controls to mitigate those hazards. FDA's GMP regulations also specify the appropriate procedures that companies should implement to ensure that employees are properly trained, facilities are maintained and operated in a sanitary way, and incoming raw materials are screened and processed to ensure their suitability for use as food. Proper implementation of these regulatory requirements goes a long way toward preventing a food safety issue from arising.

Notably, FDA's regulations at 21 C.F.R. § 117.139 additionally require that the written food safety plan includes a recall plan for food with a hazard that requires a preventive control. FDA's regulations dedicated to recalls at 21 C.F.R. §§ 7.40–7.59 reiterate the value of a written recall plan, with 21 C.F.R. § 7.59 recommending that all firms "prepare and maintain a current contingency plan for use in initiating and effecting a recall." A good practice is to perform practice runs of how a recall will be performed (referred to as a 'mock recall') before a food safety issue arises.

A wise company will also consider protecting itself from the potential legal and financial risks that may arise before a food safety issue becomes known. Good recall insurance can be an effective tool in this regard, and companies may want to ensure that the insurance adequately protects them from the exposure they might face if a large-scale recall is required. Companies also should implement policies that relate to how internal exchanges of information should proceed if a food safety issue arises, to ensure that legal counsel and other experts are involved early and stay involved, as discussed in more detail below.

Discovery of the Issue and Response

Food safety issues are ordinarily discovered in one of three ways. First, the company itself may discover the issue, perhaps through monitoring of its production processes. Second, FDA might detect an issue, perhaps during a facility inspection, which the Agency is authorized to perform under 21 U.S.C. § 374. Third, a consumer might get sick, in which case either (or both) the company and FDA may be notified via a consumer complaint.

If the issue is discovered by the company, then the nature of the problem will dictate the response. For example, perhaps equipment in a facility tested positive for Salmonella or Listeria, but it is not clear that any food is contaminated. In this case, the company should act to immediately identify the root cause of the contamination and take appropriate steps to ensure the contamination is addressed. The company also should ensure, of course, that no food is actually contaminated. Conversely, if food itself tests positive for Salmonella or Listeria, then the analysis should include a discussion about whether a recall is needed to protect public health.

If FDA discovers the issue, then the process for resolving the problem can be different, as the Agency will be involved from the start. FDA does not have the authority to compel a company to issue a food recall, except in situations where "there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death."² Still, FDA has a wide range of tools at its disposal under the Federal Food, Drug and Cosmetic Act (FD&C Act) to protect public health. If the Agency believes a recall is needed and the company is unwilling to do so, then FDA can call the company in for a regulatory meeting, issue a 483 "Notice of Inspectional Observations" report, or issue a warning letter. If the Agency believes the risk to public health is sufficiently serious, it can also commence proceedings to seize the product and may even pursue criminal charges through the Department of Justice (DOJ). Many of these tools can function to create significant negative publicity for the company.

“While handling a recall can seem like a stressful situation in the moment, the aftermath can be equally (if not more) stressful and can sometimes lead to significant and wide-ranging liability exposure for the company and its executives.”

FDA has three recall classifications: Class I, Class II, and Class III. FDA is responsible for determining the proper classification for a recall. (Note: In some cases, FDA may not consider removal of product from the market to be a recall and may instead classify it as a "market withdrawal," a determination that is reserved for situations where a product has a minor violation.) Class I recalls are the most serious and are defined as "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."³ If a company believes that a Class I recall situation may exist, then the company is obligated to submit a report to FDA via the Reportable Food Registry.⁴ This will bring the issue to FDA's attention, and FDA will likely expect the company to begin recalling the product, if it has not already started to do so.

Some of the key elements to any recall consist of:

1. A health hazard assessment by FDA to classify the recall
2. Development of the recall strategy by the company and FDA, which will consider the depth of the recall (e.g., is the recall only relevant at the distributor level, or do consumers also need to be notified?), whether a public warning is needed, and effectiveness checks to ensure downstream parties have received notification of the recall
3. Status reports submitted by the company to FDA
4. Termination of the recall.⁵

FDA also maintains a public list of all recalls on its website.⁶

As noted above, company legal departments, alone or in consultation with outside counsel, should be involved in making the decision to issue a recall. As they do, they will take care to put the company's insurers on notice of the recall and the potential for liability claims. They will also provide guidance on legal risks associated with the investigation, including issuing "hold notices," which direct personnel to retain potentially relevant documents that may be needed in litigation. They will also likely give advice on how personnel should communicate internally about the recall and underlying food safety issue. Personnel should know that everything they say will be scrutinized later, and should discuss matters in factual, neutral tones.⁷

The Aftermath

If a food safety issue can be resolved without the need for a recall and there is no risk to the public's health, then typically there is limited liability exposure for the company, provided the company takes appropriate steps to control the hazard that led to the issue in the first instance. However, if a recall is needed, then the story does not end at the time the recall is terminated. While handling a recall can seem like a stressful situation in the moment, the aftermath can be equally (if not more) stressful and can sometimes lead to significant and wide-ranging liability exposure for the company and its executives.

Consumer-Driven Liability Exposure

Recalls often lead to lawsuits. These can range from opportunistic shakedowns to serious mass tort or class action litigation. Absent serious personal injuries, most lawsuits do not lead to significant payouts, provided that companies take reasonable steps to mitigate the impact of the recall on their customers.

The most significant legal risks arise in cases where someone has become ill or died. Serious food contamination cases do not happen often, but when they do, they will usually be discovered through genetic matching between clinical isolates and isolates recovered from the plant, the product, and/or other consumers exposed to the food product. Under these circumstances, companies should naturally focus their attention on protecting public health, helping victims, and cooperating fully with regulators, retailers, and others adversely impacted by the recall. Engaging a crisis management team can assist the company in reducing brand damage.

Most food safety recalls do not cause serious personal injuries and often cause no harm other than some inconvenience. Manufacturers can minimize their legal exposure by taking logical steps to keep their customers happy. Issuing refunds and facilitating product exchanges are key steps. Unhappy consumers, at the behest of counsel, will sometimes file class action lawsuits to recover "economic damages." In a class action, a small number of plaintiffs (usually two or three) files an action to recover damages on behalf of other consumers similarly impacted by the recall. If the company has already let its customers know that they can get refunds for products discarded because of the recall, then a class action will not afford customers any better remedy. Courts frown on lawyers and lawsuits that provide no benefit to class members, so the best way to defeat such claims is simply to provide good customer service.⁸

“The FD&C Act has been interpreted to include the authority to criminally sanction senior executives or managers responsible for failure to adequately respond to the discovery of contaminated food.”

Sometimes, when it appears that the product safety issue has gone on for some time without detection, class action lawyers will file lawsuits seeking refunds or damages for products sold over an extended period of time. These actions typically fail; if consumers have used the product, obtained the product benefits they were seeking, and have not sustained personal injury, most courts conclude that the consumers have no injury to justify a lawsuit. Without any injury, they do not have a legal claim.⁹

Potential FDA Investigations and White-Collar Criminal Actions Following Food Recalls

Food recalls may lead to FDA investigations, as well as potential white-collar criminal actions. Although criminal prosecutions under the FD&C Act are rare,¹⁰ FDA's Office of Criminal Investigations (OCI) is authorized to investigate suspected criminal violations and, if appropriate, make recommendations to the DOJ for prosecution.¹¹

FDA Investigations. OCI has the primary responsibility for all criminal investigations conducted by FDA.¹² OCI will often work with the Federal Bureau of Investigation (FBI), the Centers for Disease Control and Prevention (CDC), or state agencies to investigate suspected criminality.¹³ FDA usually offers the opportunity to comply voluntarily prior to initiating a criminal prosecution, as long as "a violative situation does not present a danger to health or does not constitute intentional, gross, or flagrant violations."¹⁴ In 2010, following a recall of Salmonella-infected eggs, FDA conducted an inspection of Quality Egg LLC.¹⁵ FDA found unsanitary conditions and produced a report detailing the steps necessary for the company to address the contamination.¹⁵ When FDA conducted a follow-up investigation and found that the company failed to implement the required changes, FDA pursued criminal action against the company's executives.¹⁶

Potential Criminal Actions Following a Recall. Failure to abide by the FD&C Act can be a criminal act, punishable by fines and possible imprisonment. FD&C Act Section 301 makes it illegal to distribute, directly or indirectly, a covered product in interstate commerce that is adulterated or misbranded.¹⁷ Although less than 1 percent of FDA inspections result in criminal prosecution, the FD&C Act carries the threat of significant criminal penalties.¹⁴ The standard for criminal liability under the FD&C Act is strict liability.

Failure to stop the dissemination of contaminated food causing harm may result in criminal penalties for a company. For example, in 2015, ConAgra Grocery Products LLC pled guilty and paid $11.2 million in connection with the shipment of contaminated peanut butter.¹⁸ In February 2007, FDA announced that an ongoing outbreak of salmonellosis cases could be traced to the company's peanut butter plant.¹⁹ ConAgra then voluntarily terminated production at the impacted plant and recalled its peanut butter.¹⁸ As part of the plea agreement, the company admitted that it had previously been aware of some risk of Salmonella contamination in peanut butter, and although efforts to address some of these issues had occurred or were underway, the company did not sufficiently address or correct the threats.¹⁸

The FD&C Act has been interpreted to include the authority to criminally sanction senior executives or managers responsible for failure to adequately respond to the discovery of contaminated food. The Park Doctrine, also known as the "Responsible Corporate Officer" Doctrine, allows corporate officials to be convicted of misdemeanors under the FD&C Act if they "had, by reason of [their] position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and [they] failed to do so."¹⁹ This strict liability arises when the individual had a "responsible relationship" to the omission or action that violated the statute.²⁰ Although the Doctrine does not require awareness of wrongdoing, liability requires the defendant to have had the power to prevent harm but still failed to do so.²¹ A defendant may raise "powerlessness" to prevent or correct the violation as a valid defense.²² The Doctrine has the practical effect of placing a high duty of care on corporate officials in the food and drug industry.²²

The potential for severe individual officer liability was demonstrated in 2015, when several former officials of the Peanut Corporation of America (PCA) were sentenced to prison for up to 28 years.²³ The officers were convicted for perpetuating the distribution of contaminated products and evading FDA review during what would become one of the most extensive food recalls in U.S. history.²³

Takeaway

Clearly, there are a wide range of important legal issues to consider when a food safety issue arises, including many that a company may not immediately appreciate. Legal problems, like food safety problems, do not get better without prompt, professional attention. For this reason, it can be helpful to work with qualified legal professionals to navigate such situations.

Note

The findings and conclusions of this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).

References

1. U.S. Food and Drug Administration (FDA). Food Safety Modernization Act. Pub. L. No. 111–353, 124 Stat. 3885 (2011).
2. See 21 U.S.C. § 350I and 21 C.F.R. § 7.40(a). A recall is ordinarily "a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health from products that present a risk of injury or gross deception or are otherwise defective."
3. FDA. "Recalls Background and Definitions." Content current as of July 31, 2014. https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions.
4. FDA. "Reportable Food Registry for Industry." Content current as of March 28, 2022. https://www.fda.gov/food/compliance-enforcement-food/reportable-food-registry-industry.
5. See 21 C.F.R. §§ 7.40–7.59.
6. FDA. "Recalls, Market Withdraws, and Safety Alerts." Content current as of July 10, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.
7. See Anscombe, A. and K. Woodward. "What Food Professionals Can Learn From GM about Internal Safety Communications." Food Safety Magazine. July 1, 2014. https://www.food-safety.com/articles/4007-what-food-professionals-can-learn-from-gm-about-internal-safety-communications.
8. See, e.g., In re Aquadots Products Liability Litig, 654 F.3d 748 (7th Cir. 2011). (Class certification denied where proposed class action would not provide any benefit to which class members were not already entitled.)
9. See, e.g., In re Recalled Abbott Infant Formula Prod. Liab. Lit. 97 F. 4th 525 (2024). (Consumers who purchased potentially contaminated formula but who developed no illness had no injury.)
10. O'Reilly, J.T. Food and Drug Administration. 2nd Ed. Thomson/West, 2005.
11. FDA. "Criminal Investigations." Content current as of August 12, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/criminal-investigations.
12. FDA. "Chapter 8: Investigations." Investigations Operations Manual 2022. https://www.fda.gov/media/75268/download.
13. FDA. "Criminal Case Activity." Content current as of August 12, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/what-we-investigate/criminal-case-activity.
14. Staman, Jennifer A. "Enforcement of Food, Drug, and Cosmetic Act: Select Legal Issues." Congressional Research Service. February 9, 2018. https://www.congress.gov/crs-product/R43609.
15. See United States v. Quality Egg, LLC, 99 F. Supp. 3d 920, 931 (N.D. Iowa, 2015).
16. See United States v. DeCoster, 828 F.3d 626, 631 (8th Cir. 2016). (The company executives were charged as responsible corporate officers, paid a $100,000 fine, and were sentenced to three months in prison.)
17. See 21 U.S.C. § 331.
18. U.S. Department of Justice (DOJ). "ConAgra Subsidiary Agrees to Enter Guilty Plea in Connection with 2006 through 2007 Outbreak of Salmonella Poisoning Related to Peanut Butter." Press Release. May 20, 2015. https://www.justice.gov/archives/opa/pr/conagra-subsidiary-agrees-enter-guilty-plea-connection-2006-through-2007-outbreak-salmonella#:~:text=ConAgra%20Grocery%20Products%20LLC%2C%20a%20subsidiary%20of%20ConAgra,salmonellosis%2C%20or%20salmonella%20poisoning%2C%20the%20Department%20of%20Justice. (The plea agreement provides that ConAgra Grocery Products will pay a criminal fine of $8 million and forfeit assets of $3.2 million).
19. See United States v. Park, 421 U.S. 658, 674 (1975).
20. FDA. See § 8:2. Strict Liability and the "Responsible Relationship" Standard. 2023.
21. See United States v. Park, 421 U.S. at 669, 673.
22. See FDA § 8:16. Selection of criminal defendants. 2023.
23. DOJ. "Former Peanut Company President Receives Largest Criminal Sentence in Food Safety Case; Two Others also Sentenced for Their Roles in Salmonella-Tainted Peanut Product Outbreak." Press Release. September 21, 2015. https://www.justice.gov/archives/opa/pr/former-peanut-company-president-receives-largest-criminal-sentence-food-safety-case-two.