FDA Drug Recall Search

What does FDA Drug Recall Search do?

FDA Drug Recall Search queries the U.S. Food and Drug Administration's openFDA drug enforcement endpoint to retrieve detailed, structured data about pharmaceutical drug recalls. The FDA issues drug recalls when medications -- from generic tablets and capsules to injectable solutions and oral suspensions -- are found to be contaminated, mislabeled, subpotent, adulterated, or otherwise in violation of current Good Manufacturing Practice (CGMP) regulations. This actor gives you clean, programmatic access to 17,000+ drug recall enforcement reports with ten combinable filters and 26 output fields per record.

You can search by drug name (matched across brand names, generic names, and product descriptions via the openFDA enrichment layer), recalling company, reason keyword, specific recall number, recall severity classification (Class I/II/III), recall status (Ongoing/Completed/Terminated), U.S. state, and report date range. Each record includes recall identification, severity with human-readable descriptions, company and location details, product description, reason for recall, distribution scope, lot/code information, four lifecycle dates, and six openFDA cross-reference arrays covering brand names, generic names, manufacturer names, active substance names, administration routes, and NDA/ANDA application numbers.

Why use FDA Drug Recall Search on Apify?

• No API complexity -- The openFDA query syntax uses bracket-delimited date ranges, +AND+ joins, .exact field qualifiers, and multi-field OR searches across openfda.brand_name, openfda.generic_name, and product_description. This actor builds the correct query from simple input fields.
• openFDA enrichment built in -- Raw recall records are cross-referenced with the openFDA drug database to include brand names, generic names, manufacturer names, active substances, administration routes, and NDA/ANDA application numbers. No second API call needed.
• Clean date formatting -- Raw openFDA dates (YYYYMMDD) are converted to standard YYYY-MM-DD format in every output record.
• Schedule for monitoring -- Run daily or weekly on Apify to catch new drug recalls as they are published, with webhook alerts to Slack, email, or any endpoint.
• No API key required -- The openFDA API is completely free and open. The only cost is minimal Apify platform compute time.

Key features

• Drug name search across three fields -- The drug name input searches openfda.brand_name, openfda.generic_name, and product_description using OR logic, so you find recalls whether the term appears in the branded name, generic ingredient, or product listing.
• Separate reason keyword filter -- Search within recall reason text independently from the drug name. Find all NDMA contamination recalls, all CGMP deviation recalls, or all sterility failures regardless of drug.
• Direct recall number lookup -- Look up a specific recall by its FDA recall number (e.g., "D-0325-2021") for exact retrieval.
• Ten combinable filters -- Drug name, recalling firm, reason keyword, recall number, classification, status, state, date from, date to, and max results can be used in any combination.
• 26-field structured output -- Every record includes recall identification, classification with description, company details, product information, reason, distribution, dates, and six openFDA enrichment arrays.
• Run summary logging -- The actor logs a summary with classification counts, status counts, top 10 recalling firms, reason keyword frequency (contamination, CGMP, NDMA, sterility, etc.), and top 10 states.
• Automatic pagination -- openFDA limits responses to 100 records per page. The actor handles all pagination transparently, fetching up to 1,000 results across multiple API calls.
• Retry and rate limit handling -- Built-in retry logic with exponential backoff for transient errors and HTTP 429 rate limiting.

How to use FDA Drug Recall Search

1. Navigate to the FDA Drug Recall Search actor page on Apify.
2. Click Try for free to open the actor in Apify Console.
3. Enter your search parameters. At minimum, provide a drug name like "metformin" or a company name like "Aurobindo". You can also combine filters -- for example, drug name plus classification plus date range.
4. Set Max Results to control how many records you want (default 100, maximum 1,000).
5. Click Start to run the actor.
6. When the run finishes, view results in the Dataset tab. Export as JSON, CSV, Excel, or access via the Apify API.

Input parameters

Input examples

Search for metformin recalls (basic drug name search):

{
    "drugName": "metformin",
    "maxResults": 100
}

NDMA contamination recalls -- Class I only:

{
    "reasonKeyword": "NDMA",
    "classification": "Class I",
    "maxResults": 500
}

Company monitoring -- all Aurobindo recalls in 2023:

{
    "recallingFirm": "Aurobindo",
    "dateFrom": "2023-01-01",
    "dateTo": "2023-12-31",
    "maxResults": 200
}

Look up a specific recall number:

{
    "recallNumber": "D-1253-2020",
    "maxResults": 1
}

Input tips

• Use drugName for broad drug searches. It searches across brand names, generic names, and product descriptions using OR logic, so "metformin" will match brand name "METFORMIN" and generic name "METFORMIN" and any product description mentioning metformin.
• Use reasonKeyword separately from drugName. If you want all recalls mentioning NDMA regardless of drug, put "NDMA" in reasonKeyword and leave drugName blank.
• Combine filters for precision. Use drug name plus classification together to find, for example, all Class I recalls for valsartan. Add a date range to narrow to a specific time window.
• State codes are auto-uppercased. You can enter "nj" or "NJ" -- both work.
• Date ranges filter by report date. This is the date the recall was reported to the FDA, not the date the firm initiated the recall.
• Leave all filters blank is not supported -- at least one search parameter is required.

Output example

{
    "recallNumber": "D-1253-2020",
    "eventId": "85386",
    "classification": "Class II",
    "classificationDescription": "Products that might cause a temporary health problem or pose slight threat of a serious nature",
    "status": "Terminated",
    "recallingFirm": "Amneal Pharmaceuticals of New York, LLC",
    "city": "Brookhaven",
    "state": "NY",
    "country": "United States",
    "voluntaryMandated": "Voluntary: Firm initiated",
    "initialNotification": "Press Release",
    "productDescription": "Nizatidine Oral Solution, 15 mg/mL ...",
    "reasonForRecall": "CGMP Deviations: potential NDMA amounts above FDA levels",
    "distributionPattern": "Nationwide",
    "productQuantity": "11258 bottles",
    "codeInfo": "06598004A 04/2020",
    "recallInitiationDate": "2020-04-15",
    "centerClassificationDate": "2020-04-24",
    "reportDate": "2020-05-06",
    "terminationDate": "2021-09-08",
    "brandNames": ["NIZATIDINE"],
    "genericNames": ["NIZATIDINE"],
    "manufacturerNames": ["Amneal Pharmaceuticals LLC"],
    "substanceNames": ["NIZATIDINE"],
    "routes": ["ORAL"],
    "applicationNumbers": ["ANDA090576"]
}

Output fields

Core recall identification:

Location and company:

Product details:

Dates:

openFDA enrichment (cross-referenced from FDA drug database):

Use cases

• Pharmaceutical safety monitoring -- Track active drug recalls by classification, company, or drug name. Schedule daily runs with webhook alerts to Slack or email for immediate notification of new Class I recalls.
• NDMA contamination tracking -- Use reasonKeyword: "NDMA" to monitor the ongoing wave of nitrosamine impurity recalls affecting ranitidine, valsartan, metformin, and other drugs. Track which companies and formulations are impacted.
• Supply chain risk assessment -- Monitor your pharmaceutical suppliers' recall history. Filter by recalling firm to assess vendor reliability and identify companies with repeated CGMP violations.
• Competitor recall intelligence -- Track competitor drug recalls to identify market opportunities when products are withdrawn. Cross-reference with NDA/ANDA application numbers to identify specific product approvals affected.
• Regulatory compliance monitoring -- Maintain awareness of FDA enforcement trends. Analyze recall patterns by classification, reason keywords (contamination, sterility, potency, dissolution), and geographic distribution.
• Drug safety research -- Build datasets for pharmacovigilance research. Combine recall data with adverse event data from the openFDA Drug Event Monitor actor for comprehensive post-market surveillance analysis.
• Legal and litigation support -- Research recall history for specific drugs, companies, or time periods. The distribution pattern and product quantity fields help assess the scope and impact of each recall.
• State-level analysis -- Use the state filter and state summary statistics to identify geographic concentrations of pharmaceutical manufacturing quality issues.

Programmatic access (API)

Python:

from apify_client import ApifyClient

client = ApifyClient("YOUR_API_TOKEN")

run = client.actor("ryanclinton/fda-drug-recalls").call(run_input={
    "drugName": "valsartan",
    "classification": "Class I",
    "maxResults": 200,
})

for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    brands = ", ".join(item.get("brandNames", []))
    print(f"[{item['classification']}] {item['recallingFirm']}: {item['reasonForRecall'][:80]}")
    print(f"  Recall #{item['recallNumber']} | Date: {item['recallInitiationDate']} | Brands: {brands}")
    print(f"  Status: {item['status']} | Application #s: {item.get('applicationNumbers', [])}")

JavaScript:

import { ApifyClient } from "apify-client";

const client = new ApifyClient({ token: "YOUR_API_TOKEN" });

const run = await client.actor("ryanclinton/fda-drug-recalls").call({
    drugName: "valsartan",
    classification: "Class I",
    maxResults: 200,
});

const { items } = await client.dataset(run.defaultDatasetId).listItems();
const ndmaRecalls = items.filter((r) =>
    r.reasonForRecall.toLowerCase().includes("ndma"),
);
console.log(`Found ${ndmaRecalls.length} NDMA-related valsartan recalls`);
for (const r of ndmaRecalls) {
    console.log(`  ${r.recallNumber} | ${r.recallingFirm} | ${r.brandNames.join(", ")}`);
}

cURL:

# Start a run
curl "https://api.apify.com/v2/acts/ryanclinton~fda-drug-recalls/runs" \
    -X POST \
    -H "Content-Type: application/json" \
    -H "Authorization: Bearer YOUR_API_TOKEN" \
    -d '{
        "drugName": "valsartan",
        "classification": "Class I",
        "maxResults": 200
    }'

# Fetch results (after run completes)
curl "https://api.apify.com/v2/datasets/DATASET_ID/items?format=json" \
    -H "Authorization: Bearer YOUR_API_TOKEN"

How it works -- integration pipeline

Input (drugName, recallingFirm, reasonKeyword, recallNumber,
       classification, status, state, dateFrom, dateTo)
  |
  v
+-------------------------------------------------------------+
| Query Builder                                               |
| - drugName: OR across openfda.brand_name,                   |
|   openfda.generic_name, product_description                 |
| - reasonKeyword: reason_for_recall:"keyword"                |
| - recallNumber: recall_number:"D-XXXX-YYYY"                |
| - recallingFirm: recalling_firm:"FIRM"                      |
| - classification: classification.exact:"Class I"            |
| - status: status.exact:"Ongoing"                            |
| - state: state:"ST" (uppercased)                            |
| - Dates: strip dashes, wrap in [FROM+TO+TO]                 |
| - All clauses joined with +AND+                             |
+----------------------------+--------------------------------+
                             |
                             v
+-------------------------------------------------------------+
| Paginated Fetch                                             |
| api.fda.gov/drug/enforcement.json                           |
| ?search=<query>&limit=100&skip=N                            |
|                                                             |
| - 100 results per page (openFDA maximum)                    |
| - Stops at maxResults, end of data, or skip >= 1000         |
| - 404 = no matching results (returns empty)                 |
| - 429 = rate limited (exponential backoff retry)            |
| - Up to 3 retries with exponential backoff                  |
+----------------------------+--------------------------------+
                             |
                             v
+-------------------------------------------------------------+
| Transform                                                   |
| - 26 output fields per record                               |
| - Dates: YYYYMMDD -> YYYY-MM-DD (substring slicing)         |
| - classificationDescription: human-readable severity text   |
| - openFDA arrays: brand_name, generic_name,                 |
|   manufacturer_name, substance_name, route,                 |
|   application_number -> camelCase arrays                    |
| - Missing fields default to empty string or []              |
+----------------------------+--------------------------------+
                             |
                             v
+-------------------------------------------------------------+
| Output & Summary                                            |
| - Push each record to Apify dataset                         |
| - Log classification counts (Class I / II / III)            |
| - Log status counts (Ongoing / Completed / Terminated)      |
| - Log top 10 recalling firms by frequency                   |
| - Log reason keyword frequency (contamination, CGMP,        |
|   NDMA, sterility, potency, dissolution, etc.)              |
| - Log top 10 states by recall count                         |
+-------------------------------------------------------------+

openFDA query construction

The actor maps each input field to an openFDA query fragment, then joins all fragments with +AND+:

The drug name field uses OR logic across three fields (the +OR+ inside parentheses), so a single search term is matched against the branded name, generic ingredient name, and the full product description text. This is more comprehensive than the device and food recall actors, which search only two fields.

Recall classification levels

FDA classifies every drug recall into one of three severity levels based on the potential health risk:

• Class I: Most serious. The product could cause serious adverse health consequences or death. Examples: contaminated injectable drugs, drugs with incorrect active ingredients, drugs with NDMA levels far exceeding acceptable daily intake limits.
• Class II: Moderate. The product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote. Examples: drugs with subpotent active ingredients, minor CGMP deviations, packaging defects.
• Class III: Least serious. The product is unlikely to cause adverse health consequences but still violates FDA regulations. Examples: minor labeling errors, cosmetic defects, non-critical packaging issues.

Understanding the four date fields

Each recall record contains up to four dates that represent different milestones in the recall lifecycle:

Date handling

Input dates in YYYY-MM-DD format have their dashes stripped to produce the YYYYMMDD format required by the openFDA API. For example, an input of "2024-01-15" becomes 20240115 in the query. If only dateFrom is specified, the range extends to 20991231. If only dateTo is specified, the range starts from 19900101. The formatDate() function reverses this for output, converting raw YYYYMMDD responses back to YYYY-MM-DD using substring slicing.

openFDA enrichment

Unlike the basic recall enforcement fields, the openFDA enrichment arrays (brandNames, genericNames, manufacturerNames, substanceNames, routes, applicationNumbers) come from the FDA's drug product registration database. The openFDA system automatically cross-references each recall record against known drug products and appends matching data when available. This enrichment is what allows you to search by brand or generic name and get back NDA/ANDA application numbers without a second API call.

Data source

This actor queries the openFDA Drug Enforcement endpoint (https://api.fda.gov/drug/enforcement.json), which provides public access to FDA drug recall enforcement reports. The data comes from the FDA's Recall Enterprise System (RES) database and is updated regularly as new recalls are announced and existing recalls change status.

The database contains over 17,000 drug recall enforcement reports spanning multiple years, including:

• Class I (approximately 1,718 reports) -- Dangerous or defective products that could cause serious health problems or death
• Class II (approximately 14,020 reports) -- Products that might cause a temporary health problem or pose a slight threat of a serious nature
• Class III (approximately 1,674 reports) -- Products unlikely to cause adverse health reactions but that violate FDA regulations

By status: approximately 14,767 Terminated, 2,197 Ongoing, and 449 Completed.

The openFDA enrichment layer cross-references each recall with the FDA's drug registration database, adding brand names, generic names, manufacturer information, active substances, routes of administration, and NDA/ANDA application numbers when available.

How much does it cost to run?

The openFDA API is completely free with no API key required. Apify's free tier includes $5 of monthly platform credits, enough for hundreds of runs of this actor.

Tips

• Track NDMA contamination across all drugs. Use reasonKeyword: "NDMA" with no drug name filter to monitor the broad nitrosamine impurity recall wave affecting multiple therapeutic classes. The applicationNumbers field lets you identify which specific NDA/ANDA approvals are impacted.
• Combine with scheduling for real-time alerts. Set up a daily scheduled run with dateFrom set to 7 days ago and a webhook to Slack or email. This creates an automated early-warning system for new drug recalls matching your criteria.
• Use openFDA enrichment arrays for cross-referencing. The brandNames, genericNames, substanceNames, and applicationNumbers arrays come from the FDA drug database, not the recall report itself. They let you connect recalls to specific approved drug products, active ingredients, and regulatory submissions.
• Split large queries by date range. If you need comprehensive recall data for a broad search, split the query into yearly or quarterly date windows and combine results across multiple runs.

Limitations

1. 1,000 result maximum -- The actor caps output at 1,000 records per run due to openFDA skip-based pagination limits. Use date range filters to split larger datasets across multiple runs.
2. At least one filter required -- Unlike some actors in this suite, you cannot run a completely unfiltered search. Provide at least one of: drug name, recalling firm, reason keyword, recall number, classification, status, state, or date range.
3. openFDA enrichment is not always present -- The brandNames, genericNames, substanceNames, manufacturerNames, routes, and applicationNumbers arrays depend on the openFDA cross-reference matching. Some older or less common drugs may have empty arrays for these fields.
4. State filter is firm location -- The state filter matches where the recalling firm is headquartered, not where the drug was distributed. Check the distributionPattern output field for geographic distribution scope.
5. Date format required -- Dates must be entered in YYYY-MM-DD format. Other formats will produce incorrect API queries.
6. Drug recalls only -- This actor covers the /drug/enforcement.json endpoint. For medical devices, food products, or other FDA data, use the corresponding specialized actors listed below.

Responsible use

• FDA drug recall data is public information published by the U.S. Food and Drug Administration. Use it for safety monitoring, research, compliance, and consumer protection.
• Follow the openFDA Terms of Service when using the data.
• A recall does not mean a drug is always dangerous. Class III recalls address regulatory violations that are unlikely to cause harm. Always check the classification, classification description, and reason fields for context before drawing conclusions.
• When publishing or sharing recall data, provide appropriate context about recall severity and status. A terminated recall means the issue has been resolved.
• Consult healthcare professionals, pharmacists, and the FDA directly for clinical decisions. This data is for informational and research purposes.

FAQ

Do I need an API key? No. The openFDA API is completely free and requires no authentication. You only need an Apify account to run the actor.

How current is the recall data? The openFDA database is updated regularly by the FDA. Most recalls appear within days of being officially announced. The reportDate field indicates when each recall entered the database.

What is the difference between Class I, II, and III recalls? Class I is the most serious -- the drug could cause serious health problems or death (e.g., NDMA contamination at dangerous levels). Class II means the drug may cause temporary or reversible health problems. Class III means the drug is unlikely to cause harm but still violates FDA regulations (e.g., minor labeling errors).

What are the openFDA enrichment fields? The arrays brandNames, genericNames, manufacturerNames, substanceNames, routes, and applicationNumbers are cross-referenced from the FDA drug registration database. They provide additional context about the drug product beyond what the recall report itself contains. Not every recall record has enrichment data -- some older or less common drugs may have empty arrays.

What are NDA and ANDA application numbers? NDA (New Drug Application) numbers identify original brand-name drug approvals. ANDA (Abbreviated New Drug Application) numbers identify generic drug approvals. The applicationNumbers field contains these identifiers, allowing you to trace recalled products back to their specific FDA approval.

Can I search for non-drug recalls? No. This actor queries the /drug/enforcement endpoint only. For medical device recalls, see FDA Medical Device Recall Search. For food recalls, see FDA Food Recall Monitor.

What does "Terminated" status mean? A terminated recall means the FDA has determined that all reasonable efforts have been made to remove or correct the product. The issue has been resolved. An "Ongoing" recall is still active, and "Completed" means the firm has completed its correction/removal but FDA has not yet formally terminated the recall.

Can I get more than 1,000 results? The actor caps at 1,000 per run. For larger datasets, use date range filters to split queries into smaller time windows (e.g., one year at a time) and combine the results across multiple runs.

Related actors

This actor is part of a suite of FDA and regulatory data actors. Use them together for comprehensive pharmaceutical and medical product safety monitoring:

Connect with any Apify integration including Google Sheets, Zapier, Make (Integromat), Amazon S3, and custom API endpoints to build automated pharmaceutical safety monitoring workflows.