TL;DR: A voluntary food recall is usually company-led action taken after its own tests or at the regulator's request, while a mandatory recall is an FDA order used when a firm will not act.

Voluntary recalls cover almost every FDA action

Most FDA recalls are voluntary, initiated by the company or at the FDA's request, according to FDABridge.

A voluntary recall is one that a company initiates on its own, without being ordered to do so by a government agency, according to Recall Radar.

That label does not mean the company found a trivial problem and decided to be proactive, according to Recall Radar.

It usually means one of two things: either the company found the problem through its own testing and quality systems and moved ahead of a government investigation, or the FDA, USDA, NHTSA, or CPSC identified the problem and asked the company to recall, according to Recall Radar.

The second scenario is extremely common, according to Recall Radar.

Government agencies often contact manufacturers when they identify a safety concern, explain what they have found, and request a voluntary recall, according to Recall Radar.

The manufacturer, facing the alternative of a public mandatory recall order, which is worse for its reputation and potentially triggers more regulatory scrutiny, agrees to cooperate, according to Recall Radar.

The result is labeled voluntary, even though the practical difference between a requested voluntary recall and a mandatory one is close to zero from the consumer's perspective, according to Recall Radar.

The vast majority of FDA recalls are voluntary — the manufacturer, distributor, or importer initiates the recall, often after discovering a compliance problem through internal testing, consumer complaints, or FDA notification, according to FDABridge.

Voluntary recalls may be conducted with or without FDA involvement, but the FDA monitors all recalls and may request additional actions if the company's efforts are insufficient, according to FDABridge.

An analysis of public FDA records by Fonteum found 99.4% of recalls are firm-initiated, with only 0.5%, or 302 recalls, listed as FDA-mandated.

The word voluntary in a recall notice does not signal that the recall is precautionary or that the hazard is minor, according to Recall Radar.

Some of the deadliest recalls in U.S. history — including the Takata airbag inflator recall that killed more than 30 people — were technically voluntary, according to Recall Radar.

Mandatory recalls require a refusal or failed voluntary effort

Mandatory recalls occur when a company refuses to voluntarily recall a product that an agency has determined poses a safety risk, according to Recall Radar.

This is relatively rare because most companies comply with government requests rather than face the legal, reputational, and financial consequences of a public fight with a federal agency, according to Recall Radar.

FSMA Section 206 gave the FDA authority to order mandatory recalls of food products when voluntary recall efforts are inadequate and when the FDA determines that there is a reasonable probability that the food is adulterated or misbranded and that the use of or exposure to the food will cause serious adverse health consequences or death, according to FDABridge.

The FDA gained the authority to order mandatory food recalls in 2011 under the Food Safety Modernization Act, known as FSMA, according to Recall Radar.

Before that, the FDA could only request voluntary recalls for most food products, according to Recall Radar.

For drugs and devices, the FDA has separate mandatory recall authorities under other provisions of the FD&C Act, according to FDABridge.

The CPSC has long had mandatory recall authority under the Consumer Product Safety Act, according to Recall Radar.

NHTSA can order mandatory vehicle recalls under the National Traffic and Motor Vehicle Safety Act, according to Recall Radar.

When you see a mandatory recall, it typically means there was a dispute between the manufacturer and the agency, or the manufacturer was unresponsive, according to Recall Radar.

The safety concern itself is usually the same whether the recall is voluntary or mandatory — the distinction reflects the legal mechanism, not the severity of the hazard, according to Recall Radar.

Class I, II and III describe health risk, not willingness

The FDA classifies recalls based on the severity of the health risk, according to FDABridge.

The more meaningful indicator of a recall's seriousness is its classification: Class I, Class II, or Class III, according to Recall Radar.

These classifications apply to FDA and USDA recalls and are based on the assessed health risk, not on whether the recall was voluntary or mandatory, according to Recall Radar.

A Class I recall means the agency has determined there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death, according to Recall Radar.

Class I recalls involve situations where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death, according to FDABridge.

Examples include food contaminated with Clostridium botulinum toxin, drugs with incorrect active ingredient concentrations, or devices that could cause fatal injuries, according to FDABridge.

Most food recalls involving Listeria, Salmonella, or E. coli are Class I, according to Recall Radar.

Most drug recalls involving dangerous contamination are Class I, according to Recall Radar.

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or that serious harm is possible but unlikely, according to Recall Radar.

Class II recalls involve situations where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is remote, according to FDABridge.

A Class III recall means the product is unlikely to cause any health consequences but violates regulations, according to Recall Radar.

Class III recalls involve situations where the use of or exposure to a violative product is not likely to cause adverse health consequences, according to FDABridge.

The classification determines the urgency and scope of the recall actions required, according to FDABridge.

Read the recall classification and the reason for recall to understand the actual risk level, according to Recall Radar.

NHTSA vehicle recalls and CPSC product recalls use different language — NHTSA does not use the Class I/II/III system — but NHTSA safety recalls are inherently serious because they involve defects that can impair vehicle operation, according to Recall Radar.

What a recalling food firm must do

When a recall is initiated, the recalling firm must notify the FDA, according to FDABridge.

The firm must identify all affected product by lot number, production date, and distribution records, according to FDABridge.

It must notify all direct accounts, including distributors, retailers, and food service operators, that received the product, according to FDABridge.

It must arrange for the return or destruction of recalled product, according to FDABridge.

It must issue public notification when required by the FDA, typically for Class I and Class II recalls, according to FDABridge.

It must provide the FDA with regular status reports on the recall's effectiveness, according to FDABridge.

The FDA evaluates the recall's progress through audit checks — verifying that the recalling firm's notifications reached their intended recipients and that affected product is being removed from commerce, according to FDABridge.

Even when a company agrees to a voluntary recall, the process takes time, according to Recall Radar.

The company must identify the scope of the affected product — which lots, which date ranges, which distribution channels, according to Recall Radar.

It must arrange for the product to be pulled from store shelves, which requires coordinating with distributors and retailers across the country, according to Recall Radar.

Withdrawals and alerts are not recalls

A market withdrawal is distinct from both voluntary and mandatory recalls, according to Recall Radar.

It occurs when a company removes a product from the market for a reason that does not constitute a regulatory violation, according to Recall Radar.

The problem might be a quality issue — off flavor, discoloration, or a packaging defect — that does not pose a safety risk and does not violate FDA or USDA standards, according to Recall Radar.

Market withdrawals are not tracked by government agencies the same way recalls are, and they do not appear in official recall databases, according to Recall Radar.

Consumers typically learn about them through retailer communications or media coverage, according to Recall Radar.

Because there is no health risk involved, market withdrawals do not require the same consumer action as a recall, according to Recall Radar.

Safety alerts and public health notifications are also distinct from recalls, according to Recall Radar.

The FDA sometimes issues safety alerts about products that have not been recalled but pose a potential risk — for example, alerting consumers to fraudulent or counterfeit products in the market, according to Recall Radar.

These are not recalls and do not require the same response, according to Recall Radar.

Imported-food recalls add importer duties

When a recalled product was manufactured abroad, the foreign manufacturer must cooperate with the U.S. importer and distributor to provide the information needed for an effective recall, according to FDABridge.

This includes providing production records that identify the affected lots, according to FDABridge.

It includes providing distribution records showing where the product was shipped, according to FDABridge.

It includes providing manufacturing and testing records that may help identify the root cause, according to FDABridge.

It includes ongoing communication about corrective actions being taken at the manufacturing facility, according to FDABridge.

The foreign manufacturer should also halt further shipments of the affected product until the root cause has been identified and corrected, according to FDABridge.

While the FDA's primary enforcement contact during a recall is typically the U.S. importer or distributor, the foreign manufacturer's cooperation is essential, according to FDABridge.

Refusal to cooperate can result in import alerts and other enforcement actions against the facility, according to FDABridge.

What the public record shows

All recalls are reported in the FDA's Enforcement Reports, which are published weekly and are publicly searchable, according to FDABridge.

The recall report includes the product name, the recalling firm, the reason for the recall, the recall classification, and the distribution information, according to FDABridge.

Recall information is permanent — once published, it remains in the FDA's database indefinitely, according to FDABridge.

Fonteum counted 56,777 FDA recall reports in the database, plus 3,574 warning letters.

Of all 56,777 recall records, Class II accounts for 86%, Class I for 9.2%, and Class III for 4.8%, according to Fonteum.

Medical devices account for 68.9% of recalls, at 39,095 recalls, with drugs accounting for the remaining 31.1%, at 17,682 recalls, according to Fonteum.

The data run through June 2026 as a partial year, with volume peaking in 2018-2019 above 4,600 per year and stabilizing near 3,600 to 3,800 after 2020-2021, according to Fonteum.

The bottom line for shoppers: pay more attention to the recall class than to whether it is described as voluntary or mandatory, according to Recall Radar.

Sources referenced