FDA

Drug recalls, food recalls and medicine labels

FDA provides drug safety data, latest matching drug labels, common reported side effects, and newest-first drug, food, and device recalls; recent drug and device recalls may be missing, and weekly food statuses may lag.

Get drug label

Get the latest matching FDA drug label for a brand or generic medicine, including uses, directions, safety sections, ingredients and a DailyMed link. Some sections are absent from individual labels.

Your information

Medicine

The brand or generic medicine name, for example Tylenol or sertraline.

1 credit per run

Example results

Type: Over the counter
Used for: Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever
Warnings: Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease a breathing problem such as chronic bronchitis glaucoma persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts These ...
Brand Name: Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE
How to Take: Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours, while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Generic Name: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer: Kenvue Brands LLC
Boxed Warning: Not provided
Dailymed Link: dailymed.nlm.nih.gov
Active Ingredients: Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant
Common Side Effects: When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children
Label Effective Date: 2026-08-25
Pregnancy Information: Not provided

Example data · Run in Studio for fresh results.

About FDA

FDA (openFDA) searches drug, food, and device recalls using a medicine, company, product, allergen, or device name.

Get drug label uses a brand or generic medicine name to return label uses, directions, ingredients, and safety sections.

Get reported side effects uses a brand or generic medicine name to return frequently reported reactions and report counts.

Built by Fous from open.fda.gov and checked automatically; it last passed a check on Sep 28, 2026. Fous is not affiliated with FDA.

Actions

Get drug label

1 credit per run

Get the latest matching FDA drug label for a brand or generic medicine, including uses, directions, safety sections, ingredients and a DailyMed link. Some sections are absent from individual labels.

What you provide

Field	Type	Required	Description
Medicine`medicine`	Text	Required	The brand or generic medicine name, for example Tylenol or sertraline.Example: Tylenol

What you get

Field	Type	Description
Type`type`	Text	Prescription or over the counter.Example: Over the counter
Used for`used_for`	Text	Uses and indications from the label.Example: Uses temporarily relieves the following cold/flu symptoms: minor aches and…
Warnings`warnings`	Text	Warnings or warnings and precautions from the label.
Brand Name`brand_name`	Text	Brand name on the selected label.Example: Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE
How to Take`how_to_take`	Text	Directions or dosage and administration from the label.
Generic Name`generic_name`	Text	Generic name on the label.Example: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer`manufacturer`	Text	Manufacturer or labeler listed by the FDA.Example: Kenvue Brands LLC
Boxed Warning`boxed_warning`	Text	Boxed warning, if any.
Dailymed Link`dailymed_link`	Text	Link to the label on DailyMed.Example: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b95905e-b729-4caf-921…
Active Ingredients`active_ingredients`	Text	Active ingredients and strengths from the label, when available.Example: Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain…
Common Side Effects`common_side_effects`	Text	Adverse reactions or side effects listed on the label.Example: When using this product do not exceed recommended dose (see overdose warning )…
Label Effective Date`label_effective_date`	Text	Date this label became effective, in YYYY-MM-DD format.Example: 2026-08-25
Pregnancy Information`pregnancy_information`	Text	Pregnancy information in the label.

Example result

For Medicine: Tylenol

JSON

{
  "type": "Over the counter",
  "used_for": "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever",
  "warnings": "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containi…",
  "brand_name": "Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE",
  "how_to_take": "Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on…",
  "generic_name": "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE",
  "manufacturer": "Kenvue Brands LLC",
  "boxed_warning": null,
  "dailymed_link": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b95905e-b729-4caf-921a-fc4ef815289c",
  "active_ingredients": "Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant",
  "common_side_effects": "When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in chi…",
  "label_effective_date": "2026-08-25",
  "pregnancy_information": null
}

Get reported side effects

1 credit per run

Get the most frequently reported reaction terms for a brand or generic medicine in FDA adverse-event reports. Reports can include non-symptom terms and do not establish causation.

What you provide

Field	Type	Required	Description
Medicine`medicine`	Text	Required	Brand or generic medicine name, for example Ozempic.Example: Semaglutide
Max Results`max_results`	Number	Optional	Maximum number of reaction terms to show, for example 20.Example: 3

What you get

Field	Type	Description
Reactions`reactions`	List	Reaction terms, ordered by report count from highest to lowest. Some terms describe use or reporting rather than symptoms.
Page URL`reactions[].page_url`	Text	FDA results for reports matching this medicine and reaction.Example: https://api.fda.gov/drug/event.json?search=%28patient.drug.medicinalproduct.exa…
Reaction`reactions[].reaction`	Text	FDA reaction term in words.Example: Nausea
Report Count`reactions[].report_count`	Number	Number of matching reports listing this reaction.Example: 11534
Share of All Reports (%)`reactions[].share_of_all_reports_percent`	Number	Percentage of all matching reports listing this reaction.Example: 14.46
Total Reports`total_reports`	Number	Total FDA adverse-event reports mentioning the medicine.Example: 79767
Causality Note`causality_note`	Text	Caution about interpreting reports.Example: These reports do not prove the medicine caused the reaction. Reporting rates…
Medicine Name Matched`medicine_name_matched`	Text	Medicine name used to find matching reports.Example: Semaglutide
Serious Reports (%)`serious_reports_percent`	Number	Percentage of matching reports marked serious.Example: 51.96

Example result

For Medicine: Semaglutide, Max Results: 3

JSON

{
  "reactions": [
    {
      "page_url": "https://api.fda.gov/drug/event.json?search=%28patient.drug.medicinalproduct.exact%3A%22SEMAGLUTIDE%22+OR+patient.drug.openfda.brand_name.exact%3A%22SEMAGLUTIDE%22+OR+patient.drug.openfda.generic_name%…",
      "reaction": "Nausea",
      "report_count": 11534,
      "share_of_all_reports_percent": 14.46
    },
    {
      "page_url": "https://api.fda.gov/drug/event.json?search=%28patient.drug.medicinalproduct.exact%3A%22SEMAGLUTIDE%22+OR+patient.drug.openfda.brand_name.exact%3A%22SEMAGLUTIDE%22+OR+patient.drug.openfda.generic_name%…",
      "reaction": "Off label use",
      "report_count": 7774,
      "share_of_all_reports_percent": 9.75
    },
    {
      "page_url": "https://api.fda.gov/drug/event.json?search=%28patient.drug.medicinalproduct.exact%3A%22SEMAGLUTIDE%22+OR+patient.drug.openfda.brand_name.exact%3A%22SEMAGLUTIDE%22+OR+patient.drug.openfda.generic_name%…",
      "reaction": "Vomiting",
      "report_count": 7693,
      "share_of_all_reports_percent": 9.64
    }
  ],
  "total_reports": 79767,
  "causality_note": "These reports do not prove the medicine caused the reaction. Reporting rates cannot be used to estimate the chance of a side effect.",
  "medicine_name_matched": "semaglutide",
  "serious_reports_percent": 51.96
}

Search device recalls

1 credit per run

Find FDA medical device recalls by device or company name, newest first. Records may lag recent recall activity; consult the FDA record for current guidance.

What you provide

Field	Type	Required	Description
Query`query`	Text	Required	Device or company name to search, for example insulin pump or Philips.Example: insulin pump
Since Date`since_date`	Date	Optional	Include recalls initiated on or after this date, for example 2025-01-01. Leave blank for no date limit.Example: 2026-08-01
Max Results`max_results`	Number	Optional	Most recalls to return, for example 20. Maximum 100.Example: 5

What you get

Field	Type	Description
Device Recalls`device_recalls`	List	Medical device recalls ordered by initiation date, newest first.
Reason`device_recalls[].reason`	Text	Reason for the recall.
Status`device_recalls[].status`	Text	FDA-published recall status.
Company`device_recalls[].company`	Text	Company recalling the device.
Page URL`device_recalls[].page_url`	Text	FDA page for this individual recalled device.
What to Do`device_recalls[].what_to_do`	Text	FDA-published recall action or instructions, when stated.
Device Name`device_recalls[].device_name`	Text	FDA product description of the recalled device.
Recall Date`device_recalls[].recall_date`	Date	Date the firm initiated the recall.
Seriousness`device_recalls[].seriousness`	Text	FDA recall class and its health-risk meaning, when classified.
Product Code`device_recalls[].product_code`	Text	FDA product code.
Recall Number`device_recalls[].recall_number`	Text	FDA recall number.

Example result

For Query: nonsuchimpossibledevicename482907, Max Results: 3

JSON

{
  "device_recalls": []
}

Search drug recalls

1 credit per run

Find FDA drug recalls by medicine or company name, newest first. Covers FDA drug enforcement records; recent recalls may not yet appear.

What you provide

Field	Type	Required	Description
Query`query`	Text	Required	Medicine or company name, for example metformin or Pfizer.Example: Metformin
Status`status`	Text	Optional	Recall status to include, for example ongoing.Example: Ongoing
Since Date`since_date`	Date	Optional	Include recalls started on or after this date, for example 2024-01-01.Example: 2024-01-01
Max Results`max_results`	Number	Optional	Maximum number of recalls to return, for example 20.Example: 5

What you get

Field	Type	Description
Recalls`recalls`	List
Reason`recalls[].reason`	Text	Reason for the recall.Example: Lack of Assurance of Sterility.
Status`recalls[].status`	Text	Current recall status in words.Example: Ongoing
Company`recalls[].company`	Text	Recalling company.Example: PFIZER INC
Page URL`recalls[].page_url`	Text	Link to this FDA recall record.Example: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0590-2025…
Seriousness`recalls[].seriousness`	Text	FDA recall class and what it means.Example: Class II: may cause temporary or reversible health problems
Recall Number`recalls[].recall_number`	Text	FDA recall number.Example: D-0590-2025
Distributed in`recalls[].distributed_in`	Text	Areas where the medicine was distributed.Example: U.S. Nationwide
Quantity Recalled`recalls[].quantity_recalled`	Text	Quantity recalled, including units.Example: 49,620 vials
Recall Start Date`recalls[].recall_start_date`	Text	Date the recall began, YYYY-MM-DD.Example: 2025-08-04
Product Description`recalls[].product_description`	Text	Recalled medicine and packaging description.Example: Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only…

Example result

For Query: Pfizer, Status: Ongoing, Since Date: 2024-01-01, Max Results: 5

JSON

{
  "recalls": [
    {
      "reason": "Lack of Assurance of Sterility.",
      "status": "Ongoing",
      "company": "PFIZER INC",
      "page_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0590-2025%22&limit=1",
      "seriousness": "Class II: may cause temporary or reversible health problems",
      "recall_number": "D-0590-2025",
      "distributed_in": "U.S. Nationwide",
      "quantity_recalled": "49,620 vials",
      "recall_start_date": "2025-08-04",
      "product_description": "Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05.  Case: NDC 0409-4933-10."
    },
    {
      "reason": "Lack of Assurance of Sterility.",
      "status": "Ongoing",
      "company": "PFIZER INC",
      "page_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0591-2025%22&limit=1",
      "seriousness": "Class II: may cause temporary or reversible health problems",
      "recall_number": "D-0591-2025",
      "distributed_in": "U.S. Nationwide",
      "quantity_recalled": "15,750 vials",
      "recall_start_date": "2025-08-04",
      "product_description": "Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24.  Case NDC: 00409-6637-14."
    }
  ]
}

Search food recalls

1 credit per run

Find FDA food recall enforcement reports by product, brand, or allergen, newest first. Reports are updated weekly and recall statuses may lag.

What you provide

Field	Type	Required	Description
Query`query`	Text	Required	Product, brand, or allergen to search for, for example peanut or ice cream.Example: ice cream
State`state`	Text	Optional	State name or two-letter code where the recall was distributed, for example California or CA.Example: New York
Since Date`since_date`	Date	Optional	Earliest recall start date in YYYY-MM-DD, for example 2025-01-01.Example: 2025-01-01
Max Results`max_results`	Number	Optional	Most recalls to return, for example 20 (maximum 100).Example: 5

What you get

Field	Type	Description
Recalls`recalls`	List	Matching food recalls, newest first.
Reason`recalls[].reason`	Text	Reason for the recall.Example: Foreign object: products may contain glass pieces
Status`recalls[].status`	Text	Recall status in words.Example: Ongoing
Company`recalls[].company`	Text	Recalling company.Example: Dreyer's Grand Ice Cream Inc.
Page URL`recalls[].page_url`	Text	Link to this recall record.Example: https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22H-1265-2026…
Seriousness`recalls[].seriousness`	Text	Health risk classification explained in words.Example: Class II: may cause temporary or reversible health problems
Recall Number`recalls[].recall_number`	Text	FDA recall number.Example: H-1265-2026
Distributed in`recalls[].distributed_in`	Text	Where the recalled product was distributed.Example: The adulterated product was distributed to the following States: AL, AR, AZ…
Recall Start Date`recalls[].recall_start_date`	Date	Date the recall began.Example: 2026-08-18
Product Description`recalls[].product_description`	Text	Recalled product.Example: Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624…

Example result

For Query: ice cream, State: New York, Since Date: 2025-01-01, Max Results: 5

JSON

{
  "recalls": [
    {
      "reason": "Foreign object: products may contain glass pieces",
      "status": "Ongoing",
      "company": "Dreyer's Grand  Ice Cream Inc.",
      "page_url": "https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22H-1265-2026%22",
      "seriousness": "Class II: may cause temporary or reversible health problems",
      "recall_number": "H-1265-2026",
      "distributed_in": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.",
      "recall_start_date": "2026-08-18",
      "product_description": "Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder."
    },
    {
      "reason": "Foreign object: products may contain glass pieces",
      "status": "Ongoing",
      "company": "Dreyer's Grand  Ice Cream Inc.",
      "page_url": "https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22H-1266-2026%22",
      "seriousness": "Class II: may cause temporary or reversible health problems",
      "recall_number": "H-1266-2026",
      "distributed_in": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.",
      "recall_start_date": "2026-08-18",
      "product_description": "Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder."
    }
  ]
}

For developers

Run this workflow from your own code. In Studio, turn on Developer mode and create an API key.

cURL

# First set your key: export FOUS_API_KEY='YOUR_FOUS_API_KEY'
: "${FOUS_API_KEY:?Set FOUS_API_KEY before running this example}"

curl 'https://api.fous.com/v1/query' \
  --fail-with-body --silent --show-error --max-time 120 \
  -H "Authorization: Bearer $FOUS_API_KEY" \
  -H 'Content-Type: application/json' \
  --data-raw '{
  "api": "@fda",
  "visibility": "public",
  "operation": "get_drug_label",
  "version": 1,
  "input": {
    "medicine": "Tylenol"
  },
  "response": {
    "format": "json"
  }
}'

What you can do with it

Track recalls affecting medicines, foods, or medical devices
Review recalled product details and health-risk classifications
Find medicine label directions, ingredients, and warnings
Compare frequently reported reactions for a medicine
Filter recall searches by date, status, or location

Questions

Is Fous affiliated with FDA?

No. Fous is not affiliated with FDA. This workflow reads the public open.fda.gov website and returns its data.

How much does it cost?

Each run costs 1 credit. With pay-as-you-go, a credit costs 1¢; monthly plans cost less per credit.

Do I need a FDA account?

No. You only need a Fous account.

How current is the data?

Fous gets the data from open.fda.gov when you run it; repeating the same request within a day may return the saved result. Fous checks this workflow automatically; it last passed a check on Sep 28, 2026.