🛡️ US FDA Recall Watch (Drug, Device, Food)

Follow FDA enforcement recalls across drugs, devices and food for lifecycle movement — a recall's status changing (Ongoing → Completed or Terminated) and its classification being revised — as a change feed keyed on the source-native recall number. Public openFDA API, logged-out, no key. It reports what the enforcement report says; it does not assess product risk.

Output is one recall_record row per result; billing is pay-per-event, the value event being one recall delta (a $0.02 start fee per run, then $0.05 per recall delta plus one $0.10 source check per run that reads the source).

No login, no API key and no CAPTCHA solving are involved: the source is read logged-out with an identified contact User-Agent.

Who it's for

Compliance and regulatory-affairs teams, product-safety and quality teams, and supply-chain risk teams that need a dated recall change feed rather than a one-off list.

📊 Sample Output

Real rows from run gPAiFEnOP5s09JMlk on build 0.1.22 (2026-09-17), the same input as the Quick start below — every value is as the source published it (emails masked, long text shortened):

recall_number	classification	recalling_firm	country	voluntary_mandated	report_date
D-0815-2026	Class II	Baxter Healthcare Corporation	United States	Voluntary: Firm initiated	20260909
D-0811-2026	Class II	Baxter Healthcare Corporation	United States	Voluntary: Firm initiated	20260909
D-0821-2026	Class II	Baxter Healthcare Corporation	United States	Voluntary: Firm initiated	20260909
D-0813-2026	Class II	Baxter Healthcare Corporation	United States	Voluntary: Firm initiated	20260909
D-0833-2026	Class III	Supernus Pharmaceuticals, Inc.	United States	Voluntary: Firm initiated	20260909
D-0834-2026	Class II	Teva Pharmaceuticals USA, Inc	United States	Voluntary: Firm initiated	20260909
D-0824-2026	Class II	Allies Group Inc.	United States	Voluntary: Firm initiated	20260909
D-0826-2026	Class II	Allies Group Inc.	United States	Voluntary: Firm initiated	20260909

The run finished with the status message: NORMAL: emitted 24 item(s)

✅ What you get

Each row is flat JSON with these fields (from the dataset schema and the sample run; a field the source does not publish for a given row is null):

• record_key (string/null) — e.g. fda:drug:D-0815-2026
• endpoint — e.g. drug
• recall_number — e.g. D-0815-2026
• event_id — e.g. 99500
• status — e.g. Ongoing
• classification — e.g. Class II
• product_type — e.g. Drugs
• recalling_firm — e.g. Baxter Healthcare Corporation
• state — e.g. IL
• country — e.g. United States
• voluntary_mandated — e.g. Voluntary: Firm initiated
• report_date — e.g. 20260909
• report_date_iso — e.g. 2026-09-09
• recall_initiation_date — e.g. 20260806
• termination_date — null in every sample row
• reason_for_recall — e.g. CGMP Deviations
• product_description — e.g. Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY
• record_type (string) — e.g. recall_record
• delta_type (string/null) — null in every sample row

What each record contains

A recall_record (snapshot) or recall-delta (watch) carrying the enforcement-report fields as published, keyed on the source-native recall number. In watch mode each delta is NEW / CHANGED / REMOVED with before / after and changed_fields.

Every run also writes a RUN_RECEIPT record to its key-value store with the source checks it made and the counts it charged — diagnostics never land in the paid dataset.

⚙️ Sample inputs

1. Quick start — the Store example (this is what the sample above came from)

{
  "endpoints": [
    "drug"
  ],
  "limit_per_endpoint": 25,
  "watch_mode": false,
  "max_items": 40
}

The sample run charged exactly: 1 × $0.02 apify-actor-start + 1 × $0.10 source-check + 0 × $0.05 recall-delta = $0.12 on the Free tier — snapshot preview rows are delivered unbilled; only the source check and the start fee were charged.

2. A smaller, narrowed run

{
  "endpoints": [
    "drug"
  ],
  "limit_per_endpoint": 5,
  "watch_mode": false,
  "max_items": 40
}

Caps the run at 5 rows; same billing shape as the sample run above.

3. Watch mode on a schedule

{
  "endpoints": [
    "drug"
  ],
  "limit_per_endpoint": 25,
  "watch_mode": true,
  "max_items": 40
}

The first run seeds a private baseline and emits zero deltas; every later run emits one row per change, billed at $0.05 each plus the $0.10 source check; billed deltas are capped at 500 per run.

🧾 JSON sample record

One real record from run gPAiFEnOP5s09JMlk, exactly as it lands in the dataset (emails masked, long text shortened):

{
  "record_key": "fda:drug:D-0815-2026",
  "endpoint": "drug",
  "recall_number": "D-0815-2026",
  "event_id": "99500",
  "status": "Ongoing",
  "classification": "Class II",
  "product_type": "Drugs",
  "recalling_firm": "Baxter Healthcare Corporation",
  "state": "IL",
  "country": "United States",
  "voluntary_mandated": "Voluntary: Firm initiated",
  "report_date": "20260909",
  "report_date_iso": "2026-09-09",
  "recall_initiation_date": "20260806",
  "termination_date": null,
  "reason_for_recall": "CGMP Deviations",
  "product_description": "Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.",
  "record_type": "recall_record",
  "schema_version": "1.0",
  "output_mode": "preview",
  "preview_cap": 25,
  "preview_truncated": 0
}

🔧 How it works

Transport. Plain HTTPS from the Apify platform, no proxy. Every request carries an identified contact User-Agent.

Terminal states. A run ends NORMAL, CAPPED (your cap was reached), PARTIAL (something was withheld and the message says what), GENUINE_EMPTY (the source was read and truly had nothing in scope) or BLOCKED (the source refused or changed shape — the run FAILS loud and bills nothing). A zero-row run is never reported as a silent success.

Charging. Each recall delta is charged at the moment it is pushed (recall-delta); a row that fails to charge is not delivered, so the dataset count always equals the charged count. One source-check is charged per run that actually read the source.

First run and later runs — read this first

This Actor sells change detection, not bulk export. Two modes:

• Snapshot (watch_mode: false, the prefilled default): returns current enforcement records as a preview, hard-capped at 25 records regardless of max_items. Billed one source-check only — the preview records are not billed. Use it to see the data now.
• Watch (watch_mode: true): the first run seeds a private baseline and emits zero deltas (billed one source-check). Every run after emits one delta per change — the value event. A run with no movement emits zero and bills only the source-check.

openFDA refreshes the enforcement endpoints in batches, so a pass that finds no movement between refreshes is normal.

Source, scope and limits

openFDA enforcement API — drug, device and food (api.fda.gov/*/enforcement.json), logged-out only. Snapshot mode is a capped preview, not a bulk export. Terminal states: NORMAL · SUCCEEDED-0: GENUINE_EMPTY · SUCCEEDED-0 (no change) · PARTIAL · BLOCKED. A zero with no evidence fails loud rather than exiting quietly.

What is not done. No login, no cookie or CAPTCHA bypass, no private or personal-account data, no browser automation.

⏰ Set it on a schedule

A single run is a snapshot. The value is the feed: open the actor in Apify Console → Schedules → Create new, add this actor with input 3 above (watch_mode: true), and pick a cadence:

• Daily — 0 7 * * * (07:00 UTC): catch changes within a day.
• Weekly — 0 7 * * 1: a Monday digest.

The baseline persists in a named key-value store between runs, so every scheduled run compares against the last one; use a different baseline_id for independent watches. Schedules can also POST results to a webhook (Console → Integrations).

💰 Pricing example

Event	Free	Bronze	Silver	Gold
Actor Start (apify-actor-start)	$0.02	$0.02	$0.02	$0.02
Source check (source-check)	$0.10	$0.09	$0.08	$0.07
Recall Delta (recall-delta)	$0.05	$0.04	$0.04	$0.03

Worked at the live Free-tier price (watch mode, one delta per change):

• 8 recall deltas: $0.02 start + $0.10 source check + 8 × $0.05 = $0.52
• 25 recall deltas: $0.02 start + $0.10 source check + 25 × $0.05 = $1.37
• 100 recall deltas: $0.02 start + $0.10 source check + 100 × $0.05 = $5.12

A run that delivers zero rows charges the $0.02 start fee plus the $0.10 source check (the source was read and reported empty). A BLOCKED run (source refused) fails loud and charges no value event. The start fee is charged once per GB of run memory; the default run memory is 1024 MB.

Yield on the sample run: NORMAL: emitted 24 item(s). limit_per_endpoint is a hard ceiling on what is delivered and billed, never a target. Snapshot output is capped at 25 records regardless of the cap you set; watch mode is the full feed.

⚖️ Legal & ToS

This actor reads public data only. It collects only what the source publishes to any visitor, identifies itself with a contact User-Agent, and does not access accounts, private data or anything behind authentication. Use the output in line with the source's terms and your local law; the intended use is B2B research and monitoring.

❓ FAQ

Q: Do I need an API key or a login?
A: No. the input schema has no key field and the actor carries no secrets.

Q: Why did my run return 0 rows?
A: Read the run's status message. GENUINE_EMPTY means the source was read and had nothing in scope for your input (in watch mode the first run always seeds the baseline and returns zero deltas); BLOCKED means the source refused and the run failed without billing a value event — retry later or narrow the input. A zero-row run bills the start fee plus one source check.

Q: How many rows can one run return?
A: Up to limit_per_endpoint (default 100); snapshot previews stop at 25. Raise the cap for a bigger run; you pay per delivered row.

Q: What does watch mode remember between runs?
A: A private baseline of source-native record ids in a named key-value store (baseline_id names it, so several independent watches can coexist). Each later run diffs the live source against it and emits only changes.

Q: How fresh is the data?
A: Every run reads the source live at run time; nothing is cached between runs except the watch baseline. Put it on a schedule for a continuous feed.

Q: What formats can I export?
A: The dataset downloads as JSON, CSV, Excel, XML or RSS from the run's Dataset tab or the Apify API, and any run can push to a webhook or integration.

Q: How is this different from the other product safety and approvals watches actors?
A: Same output shape and billing model; this one covers US FDA Recall Watch (Drug, Device, Food). The siblings under Related Actors cover the other sources or slices — run several on one schedule for a combined feed.

🆘 Troubleshooting

• Run FAILED with BLOCKED → the source refused the request or changed its page shape → nothing was billed beyond the start fee; retry after a while, and if it persists open an Issue with the run id.
• Status says CAPPED → your cap (limit_per_endpoint) was reached → raise it for a bigger run.
• Input validation error on start → a field is outside the schema's allowed values → start from the Quick start block and change one field at a time.
• Run TIMED-OUT → a very wide request on a slow day → raise the run timeout in Run options or narrow the input; what was delivered before the timeout is still in the dataset.
• First watch run shows no deltas → expected: it seeds the baseline; changes appear from the second run.

🔗 Related Actors

• Japan PMDA New Drug Approval Watch — Japanese new-drug approvals as PMDA records them: approval date, brand name, marketing-authorisation holder with its corporate number, active ingredi…
• New Zealand Medsafe Recall Watch — New Zealand medicine and medical-device recall actions from the Medsafe Online Recalls Database: commencement date, product and the recall action typ…
• UK MHRA Medicine and Device Alert Watch — MHRA drug and device safety alerts as published on GOV.UK: alert title, publication timestamp and summary, keyed on the source-native GOV.UK path. LI…
• Australia ACCC Product Recall Watch — Australian consumer product recalls published by the ACCC Product Safety feed: product, recall category, publication date and summary, keyed on the s…
• 🏢 About NexGenData — NexGen Watch is NexGenData's fleet of 256 public monitoring and lookup actors built on official sources, pay-per-result. Browse the catalog at apify.com/nexgenwatch.

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