FDA Drug and Device Recalls

Data through 4 November 2026.

Drug recall records

18,110

Device recall records

40,481

Newest Enforcement Report

4 November 2026

openFDA last updated

4 November 2026

Recall records by class

Class I

1,753 drug · 3,680 device

Class II

14,632 drug · 35,760 device

Class III

1,723 drug · 1,040 device

Recall records by status

Ongoing

2,857 drug · 14,501 device

Completed

422 drug · 440 device

Terminated

14,831 drug · 25,540 device

Recall records by year initiated

2026 (to 4 November 2026)

670 drug · 2,209 device

2025

778 drug · 2,838 device

2024

557 drug · 3,280 device

2023

1,122 drug · 2,612 device

2022

1,390 drug · 2,276 device

2021

1,152 drug · 2,260 device

Source: the openFDA drug and device enforcement endpoints, which carry FDA's Enforcement Report records from 2004. Read at build time and refreshed at most daily. Each recall number is one product record, and one recall event can hold several.

The FDA recall database is the Enforcement Report: FDA's record of the recalls it monitors, each with a classification that rates the health risk. It comes from FDA's Recall Enterprise System. openFDA publishes the records for 2004 to the present as drug and device enforcement datasets, and says it updates them weekly.

A recall is a firm removing or correcting a product that violates FDA law. Almost all are voluntary: a company finds a problem and recalls the product itself, or does so after FDA raises a concern. The Enforcement Report lists a recall once FDA has classified it, and may list it earlier when FDA decides the firm's action counts as a recall. The classification is then added when FDA finishes its health hazard assessment.

This tool searches the drug and device datasets. Food recalls are the largest group and are left out, because they do not concern a regulatory or quality reader in life sciences. A recall is not a market withdrawal. A withdrawal covers a minor violation FDA would not act on, or none, and is not in the report.

FDA classifies each recall by the risk the product poses. The definitions are in 21 CFR 7.3, and the evaluation that assigns them is in 21 CFR 7.41.

• Class I. A reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. A Class I recall is the most serious category.
• Class II. Use or exposure may cause temporary or medically reversible harm, or the probability of serious harm is remote. It is the largest class in both datasets.
• Class III. The product is unlikely to cause harm but violates FDA regulations, for example a labeling error.
• Not yet classified. FDA has recorded the recall and has not yet finished classifying it.

The class describes health risk, not the number of units recalled. The FDA recall classes guide covers who assigns the class and how often each class occurs.

Recall number

FDA's identifier for one product recall, such as Z-0147-2027 for a device or a D-prefixed number for a drug. One recall event can contain many recall numbers, one for each product.

Recalling firm

The company carrying out the recall, with its city, state and country.

Classification

Class I, Class II, Class III, or not yet classified.

Status

Ongoing, Completed or Terminated. Ongoing means the recall is in progress. Completed means the firm has finished its actions. Terminated means FDA has decided the recall is complete.

Reason for recall

FDA's description of the defect, in a sentence or two. It is the most useful field for precedent searches.

Product description

What was recalled: names, sizes, models, and often the lots.

Product quantity

How much was distributed, in whatever unit the firm reported.

Distribution pattern

Where it went, from named states to nationwide and international.

Voluntary or mandated

Firm-initiated or FDA-mandated. Firm-initiated is by far the most common.

Initiation date

The day the firm began the recall. It can come well before the report date.

Report date

The Enforcement Report the record first appeared in.

Termination date

When FDA closed the recall, where it has.

Pick drugs or devices, then use any combination of the fields.

• By reason, product or firm. The first field searches all three at once. A reason rarely repeats the product name, so searching only one would miss obvious matches. Try sterility in Class I drug recalls or software in device recalls.
• By firm. Use a short form of the company name to catch its subsidiaries.
• By classification and status. Combine them to see the ongoing Class I device recalls.
• By year. A four-digit year, matched on when the recall was initiated.

Results come back newest initiation first. Every search has its own address, so you can link it in a report.

Start with the reason. It names the failure: a sterility lapse, a labeling mix-up, a software error, a contaminated lot. The reason is also the field to search when you want precedents.

Check class and status together.A Class I recall that is still ongoing is live. A Class II recall that is Terminated is history. The classification is assigned after FDA's hazard review, so a recent record may not have one yet.

One event, many records. A single recall event creates one record per product, and a kit or a product family can create many. Count events and not records when you are measuring how often a firm recalls.

Dates differ. The initiation date is when the firm acted. The report date is when FDA posted the record. FDA also records a classification date, the day it assigned the class.

A recall is one outcome of a quality failure. The others are an inspection Form 483, a warning letter, and for a product that never reaches market, a complete response letter.

The useful question for a quality team runs the opposite way to FDA's own search, which is built for finding a product you already know about. Ask what FDA has recalled for the failure mode you are worried about, and how often. Search the failure, such as sterility, particulate or cross-contamination, and read the reasons. Then look at who recalled and what class FDA assigned. Cross-check a firm with the warning letters and the inspection record.

For a device, the 510(k) database shows what cleared the product, and the MAUDE database shows the adverse event reports that often precede a recall. The product code lookup gives the class and regulation for a device category.

• Only classified or recognised recalls. A firm may announce a recall weeks before the record appears. The data block above shows the newest report date.
• Only drugs and devices here.Food and other product types are outside this search. FDA's Enforcement Report covers more.
• Quantities are the firm's figures. They use different units and are not checked.
• No outcome detail. The record does not say how many units were returned or whether anyone was harmed.
• Unvalidated. openFDA says to treat the data as unvalidated. For a decision that matters, check the entry in the Enforcement Report.

FDA's Enforcement Report. FDA publishes the report weekly, with a search page and an email subscription for new recalls, filtered by product type or keyword.

The openFDA API. The endpoints are https://api.fda.gov/drug/enforcement.json and https://api.fda.gov/device/enforcement.json. A search for Class I recalls looks like ?search=classification:"Class+I"&limit=100. Without a key openFDA allows 240 requests a minute and 1,000 a day per IP address, and a free key raises the daily limit to 120,000. Each request returns at most 1,000 records.

Bulk files. openFDA publishes each dataset as a single zipped JSON file: drugs and devices.

What do Class I, II and III mean?

Class I means a reasonable probability that the product will cause serious adverse health consequences or death. Class II means temporary or medically reversible harm, with a remote probability of serious harm. Class III means the product is unlikely to cause harm but violates FDA regulations.

What does the status mean?

Ongoing means the recall is still in progress. Completed means the firm has finished its actions. Terminated means FDA has determined the recall is complete and there is no reasonable expectation of remaining product in commerce.

Is a recall the same as a market withdrawal?

No. A recall addresses a product that violates FDA law. A market withdrawal involves a minor violation FDA would not take action over, or no violation at all. Only recalls appear in the enforcement report this searches.

Are all recalls FDA-mandated?

Most are voluntary and firm-initiated. FDA has mandatory recall authority for devices, food and a few other categories, and it is rarely used. The voluntary or mandated status is shown on each result.

Where does this data come from?

openFDA's drug and device enforcement endpoints, which carry FDA's Enforcement Report records from 2004 to the present. The search queries them live. The data block on this page gives the current record counts.

How often is the FDA recall database updated?

FDA publishes the Enforcement Report weekly, and openFDA says it updates its enforcement datasets weekly. A recall appears once FDA has recorded it, which can be weeks after the firm announces it.

Is there an API or bulk download for FDA recalls?

Yes. The openFDA endpoints are api.fda.gov/drug/enforcement.json and api.fda.gov/device/enforcement.json, limited to 240 requests a minute and 1,000 a day per IP address without a free key. Both datasets are also published as zipped JSON files.

Why can I only search drugs and devices?

openFDA also serves food enforcement, which is the largest of the three and none of it concerns a regulatory or quality reader in life sciences. It is left out deliberately.