FDA Recall Classes: Class I, II and III, and How Often Each Occurs

FDA puts each recall it monitors into one of three classes. The class states how much harm the recalled product could cause. 21 CFR 7.3(m) defines all three, and FDA assigns the class. The recalling firm does not.

In the Enforcement Report data exported on 3 November 2026, 13.9% of drug recall events and 6.6% of device recall events are Class I. For food the figure is 41.1%.

The three classes

Section 7.3(m) calls the class the "relative degree of health hazard presented by the product being recalled". It does not measure how many units were recalled or how many firms were involved.

Six records from recalls that firms began in the last months of 2025 show the range. Each recall number is listed in FDA's Enforcement Report and in openFDA. Search the same kind of records in the FDA recall search.

Who assigns the class

Under 21 CFR 7.41(a), "an ad hoc committee of Food and Drug Administration scientists" evaluates the health hazard. The factors it weighs include whether disease or injury has already occurred, the hazard to the groups most at risk, how serious the hazard is, how likely it is, and its immediate and long-range consequences. Section 7.41(b) then has FDA assign Class I, II or III on that basis.

FDA's Regulatory Procedures Manual, Chapter 7 (version 10, July 2021), describes the process. Each center has a health hazard evaluation committee. The committee returns its evaluation to the center recall unit within two working days of a recall recommendation, or five if the product is no longer in distribution. It can reuse an earlier evaluation of a similar situation. The recall unit normally classifies within two days after that. Center directors approve voluntary, firm-initiated Class I recalls under delegated authority.

The firm's part is in 21 CFR 7.46. A firm that believes its product is violative is asked to notify FDA immediately, and to supply the product identity, the reason, a risk evaluation, quantities, distribution, its recall communication and a proposed strategy. FDA reviews this and advises the firm of the class. The firm "need not delay initiation" of the removal or correction while FDA reviews.

Recall, market withdrawal, stock recovery and correction

• Recall (7.3(g)): a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which it would initiate legal action, such as seizure.
• Market withdrawal (7.3(j)): a removal or correction involving a minor violation that would not be subject to legal action, or no violation, such as normal stock rotation.
• Stock recovery (7.3(k)): a removal or correction of product that has not been marketed or has not left the firm's control.
• Correction (7.3(h)): repair, modification, adjustment, relabeling, destruction or inspection of a product without physically removing it to another location.

Market withdrawals and stock recoveries are not recalls, and the Enforcement Report leaves them out (7.50). Because the recall definition says "removal or correction", a field correction such as a software update can be a recall, and can be classified Class I, without any unit being returned.

Devices. Manufacturers and importers must report a correction or removal under 21 CFR 806.10 within 10 working days of initiating it, if it was initiated to reduce a risk to health or to remedy a violation of the Act that may present one. The definition of "risk to health" in 806.2(k) uses the same two tests as Class I and Class II. FDA's device recall page says so directly: reports are required for Class I and Class II recalls and not for Class III. Exempt actions include market withdrawals, routine servicing and stock recoveries. A firm that does not report must keep a record under 806.20 with its justification, for two years beyond the expected life of the device. The QMSR ties ISO 13485 clauses to part 806 through 820.10(b).

Strategy, communication and termination

The recall strategy covers three decisions (21 CFR 7.42(b)):

• Depth of recall: consumer or user level, retail level, or wholesale level.
• Public warning: reserved for urgent situations where other ways of keeping the product from use look inadequate, and ordinarily issued by FDA with the firm.
• Effectiveness checks: Level A contacts all consignees. Level B contacts more than 10% and fewer than 100%. Level C is 10%. Level D is 2%. Level E is no checks.

The RPM says that in general Class I recalls may extend to the consumer or user level, Class II to the retail level and Class III to the wholesale level. It adds that strategies rest on the circumstances of each recall and do not necessarily follow from the class.

Recall letters and envelopes should be marked "urgent" for Class I and Class II recalls (7.49(b)). FDA asks for status reports, generally every two to four weeks (7.53). A recall ends when FDA finds that all reasonable efforts have been made to remove or correct the product (7.55). The firm can request termination with its latest status report and a description of how the product was disposed of.

Voluntary, requested and ordered recalls

Section 7.40 describes recall as a voluntary action, and an alternative to court action. FDA can request a recall in urgent situations (7.40(b), 7.45). The RPM (7-5-3) lists where FDA has statutory authority to order one:

• food other than infant formula (section 423 of the FD&C Act)
• devices (section 518(e), 21 CFR part 810), where there is a reasonable probability that a device would cause serious adverse health consequences or death
• tobacco products (section 908(c)) and controlled substances (section 569D), through orders to cease distribution
• biological products licensed under the Public Health Service Act, where a batch or lot presents an imminent or substantial hazard (42 U.S.C. 262)
• human cells, tissues and cellular and tissue-based products (21 CFR 1271.440)

Human drugs do not appear on that list. FDA's device page calls an order under part 810 rare. In the data, 99.6% of drug records, 99.2% of device records and 98.6% of food records carry the label "Voluntary: Firm initiated".

Where the class is published

FDA lists recalls in the weekly Enforcement Report (21 CFR 7.50). Since 15 June 2017 it has also listed recalls pending classification as "not yet classified", then updates the entry. It says firms often announce a voluntary recall well before FDA classifies it. For certain drugs and devices, 7.50 lets FDA delay public notice where notice may cause unnecessary and harmful anxiety in patients and an initial consultation with their physicians is essential. Class changes after publication have been tracked since 24 July 2018.

openFDA republishes the report as drug, device and food enforcement files. The recall search tool queries the drug and device files. Adverse events for the same products are in the MAUDE search.

How often each class occurs

The counts come from openFDA's bulk enforcement files, exported 3 November 2026: 18,076 drug, 40,450 device and 29,586 food records, 88,112 in all. One record is one recalled product, so a recall with several product codes fills several records. The tool shows records. The tables below count recall events (event_id), 27,823 in all, and give an event the most serious class among its records. scripts/analyze-recall-classes.py prints every figure on this page.

Class II is the largest class for all three, at 61.8%, 89.5% and 50.7% of events. By record, Class I is 9.7% of drug records and 9.1% of device records. The record shares differ from the event shares because events vary in how many products they cover. One drug event and one food event are still "not yet classified".

Class I events by year

Year of the earliest initiation date in each event. Shares are of all events that year.

Device recall events fell from 1,232 in 2016 to 839 in 2022, then ran between 917 and 972 a year from 2023 to 2025. Class I device events rose from 38 in 2017 to 125 in 2025. Drug Class I events ran between 28 and 58 a year, and 2025 was the lowest. For food, Class I was between 34% and 39% of events in every year from 2018 to 2025. The data do not say why the device share rose. A change in what firms recall, in how FDA classifies, or in what firms report would each produce the same pattern.

Time from recall start to classification

Events that began from 2018 through 2025, in calendar days from the firm's recall initiation date to the center's classification date.

Within 60 days of initiation, FDA had classified 92.6% of drug events, 72.7% of device events and 93.1% of food events. The 90th percentile for devices is 133 days. The interval starts when the firm begins the recall, which can be before FDA hears of it, so it overstates FDA's own handling time. Of drug events 7.6% and of food events 7.8% first appeared in the Enforcement Report before their classification date. For devices it was 6 of 7,531.

Limits of these numbers

• openFDA publishes enforcement files for drugs, devices and food only. There is no biologics file, so these tables make no claim about CBER blood, vaccine and tissue recalls.
• The Enforcement Report omits market withdrawals and stock recoveries, so the counts understate what firms correct.
• Product records and events are different units. A figure from the recall tool will not match an event count here.
• The class is FDA's current entry. FDA can change it after publication.
• openFDA's own terms say to treat the data as unvalidated. Events from 2026 are partial.