Korea Drug & Medical Device Recalls (MFDS 회수·판매중지)

List recent recalls and sales suspensions of drugs and medical devices in South Korea, as published by the Ministry of Food and Drug Safety (식품의약품안전처, MFDS). Each record gives the product, the manufacturer or importer and its business registration number, the recall date, the reason, whether the recall was ordered by the regulator, and — for drugs — the product barcodes (Korean standard codes / GTIN).

No API key or Korean account needed. Pick a time window, optionally filter by product, company or business number, get English JSON.

Typical uses

• Pharmacies, distributors and online sellers — match your Korean SKUs and barcodes against new recalls every day.
• Medical device importers and hospitals — watch recalls for a device class or a supplier.
• Regulatory, quality and compliance teams — track recalls of a competitor or partner by business number.
• AI agents — "Were any Korean drugs recalled this week?", "Has 한국스트라이커 had a device recall this year?"

Input

Field	Description
categories	drug and/or medical_device. Default: both.
days	Recalls from the last N days (1-365). Default 30.
productName	Optional. Part of the Korean product name, e.g. 치약, 인공무릎관절. For devices the device class name is searched too.
companyName	Optional. Part of the Korean company name, e.g. 한미약품. (주), 주식회사 and spaces are ignored.
businessNumber	Optional. 10-digit business registration number of the company, e.g. 120-81-46949.
maxResults	Stop after this many records, newest first (1-1000). Default 50.

{ "categories": ["drug", "medical_device"], "days": 7, "maxResults": 100 }

Output

One item per recall record, newest first:

{
  "status": "recall",
  "category": "drug",
  "productName": "페인싹트리플정",
  "company": "(주)한풍제약",
  "businessNumber": "402-85-32516",
  "recallDate": "2026-10-07",
  "reason": "제품 내 이취로 인한 사전 예방 차원의 영업자 자진 회수",
  "mandatory": false,
  "drug": { "itemSeq": "202502660", "barcodes": ["8806581087209", "8806581087216"], "recallOrderDate": null },
  "device": null,
  "source": "Ministry of Food and Drug Safety (식품의약품안전처) drug recall and sales suspension list, via data.go.kr 15059114",
  "checkedAt": "2026-10-08T13:40:45+00:00"
}

{
  "status": "recall",
  "category": "medical_device",
  "productName": "골수 내 고정 막대",
  "company": "한국스트라이커(주)",
  "businessNumber": "120-81-46949",
  "recallDate": "2026-10-06",
  "reason": null,
  "mandatory": false,
  "drug": null,
  "device": {
    "receiptNo": "202600201476", "itemSeq": "200107323",
    "deviceClass": "골수 내 고정 막대", "deviceClassCode": "B03110.01", "riskGrade": 3,
    "reportType": "recall_plan", "reportTypeKo": "계획보고",
    "recallKind": "voluntary", "recallKindKo": "영업자회수보고",
    "reportState": "approved", "reportStateKo": "승인",
    "companyType": "importer"
  },
  "source": "Ministry of Food and Drug Safety (식품의약품안전처) medical device recall and sales suspension list, via data.go.kr 15056785",
  "checkedAt": "2026-10-08T13:40:28+00:00"
}

status	Meaning
recall	One recall or sales-suspension record (billed).
lookup_failed	The official list for that category did not answer; retry later (free).

An invalid input (unknown category, days outside 1-365, malformed business number) stops the run with a message and is free. No match in the window means an empty result and no record charges.

Field notes:

• mandatory: true = recall ordered by the regulator (강제 / 정부회수), false = voluntary recall by the company (자진 / 영업자회수).
• recallDate: for drugs, the date on the official recall list; for devices, the date the recall report was submitted.
• Device reportType: recall_plan (계획보고 — recall started), recall_completed (종료보고), recall_order, recall_order_withdrawn. One recall can appear as both a plan and a completion report; receiptNo identifies each report.
• riskGrade: Korean device class 1 (lowest risk) to 4 (highest).

Limits — what is not included

• Product names, company names and reasons are in Korean, as published. Field names and codes are English.
• Device recall reasons are often empty in the official data (about 9 in 10 device records); drug reasons are almost always present.
• The drug list also covers quasi-drugs (의약외품, e.g. toothpaste, masks) recalled under the drug law.
• Cosmetics and food recalls are not included (separate official lists). Device lot/serial numbers are not included.
• Looks back at most 365 days. The drug list currently starts in October 2023.
• Draft device reports (작성중) are skipped. Company addresses are not returned.

Pricing

Pay per record returned: $0.002 per recall record (recall-record). Use maxResults to cap a run. Empty results, invalid inputs and failed lookups are free.

Use as an MCP tool (Claude, Cursor, other AI agents)

Add the Apify MCP server with this Actor:

https://mcp.apify.com?tools=kr-data/korea-health-recalls

Source and license

식품의약품안전처_의약품 회수·판매중지 정보 (data.go.kr 15059114) and 식품의약품안전처_의료기기 회수·판매중지정보 (data.go.kr 15056785), 이용허락범위 제한 없음. Data is passed through unchanged except for English field names and labels, joining the device company record, and leaving out addresses and long product descriptions.

More Korean data from KR Data

• Korea Business Check (KYB) — business registration status, company profile, financials
• Korean Address to English — official English address and postal code
• Korean Law in English — official English text of Korean statutes
• Korea Flood-Damaged Car Check — flood-damage insurance records by license plate
• Korea Online Seller Registration Check — mail-order business registration (통신판매업) by business number