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Prescription medicine · generic available

Ibuprofen

Brand names: Ibu, Caldolor

Also sold without a prescription: Ibuprofen (over the counter) →

Drug class: Nonsteroidal Anti-inflammatory Drug

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
16Recalls (FDA reports)
56Companies
1986First FDA approval on file

Quick answers

What is Ibuprofen used for?
The FDA-approved label (Caldolor, Cumberland Pharmaceuticals Inc., January 29, 2026) says: “CALDOLOR is indicated in adults and pediatric patients aged 3 months and older for the: management of mild to moderate pain, including postoperative pain management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics reduction of fever CALDOLOR is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients aged 3 months and older for the …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ibuprofen have a boxed warning?
Yes. The FDA label for Caldolor has a boxed warning (“WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Ibuprofen?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ibuprofen been recalled?
FDA enforcement reports list 16 recalls of products of this medicine; the newest started October 29, 2024 (Class III). A recall usually concerns specific lots, not every product.
Who makes Ibuprofen?
56 companies list prescription products of Ibuprofen in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Aphena Pharma Solutions - Tennessee, LLC.

What Ibuprofen is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CALDOLOR is indicated in adults and pediatric patients aged 3 months and older for the: management of mild to moderate pain, including postoperative pain management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics reduction of fever CALDOLOR is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients aged 3 months and older for the …

— FDA label: Caldolor, Cumberland Pharmaceuticals Inc., effective January 29, 2026. Read the full label on DailyMed →

The FDA has 226 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Read it on the full label →

214 of 226 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Suspension · Injection
RouteOral · Intravenous
Prescription products318 in the FDA NDC Directory
Brand namesIbu, Caldolor

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ibuprofen, by strength and form
Strength and formGeneric or brandPharmacies pay
ibuprofen 100 mg/5 mL
suspension		 Generic $0.0247–$0.0435 per mL
10 packages, lowest to highest
ibuprofen 400 mg
tablet		 Generic $0.0375 per tablet
ibuprofen 400 mg
tablet, film coated		 Generic $0.0375 per tablet
ibuprofen 600 mg
tablet		 Generic $0.0461 per tablet
ibuprofen 600 mg
tablet, film coated		 Generic $0.0461 per tablet
ibuprofen 800 mg
tablet		 Generic $0.0555 per tablet
ibuprofen 800 mg
tablet, film coated		 Generic $0.0555 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA022348
CALDOLOR		 ApotexJune 11, 2009 13, latest January 23, 2026
2026: Efficacy · 2024: Labeling · 2023: Efficacy

Generic approvals (18)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. October 29, 2024 · Class III · Ongoing · D-0047-2025

    Failed Tablet/Capsule Specifications

    IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05 — Dr. Reddy's Laboratories, Inc.

  2. August 6, 2024 · Class II · Ongoing · D-0646-2024

    Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

    IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle. — Dr. Reddy's Laboratories, Inc.

  3. August 6, 2024 · Class II · Ongoing · D-0644-2024

    Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

    IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle. — Dr. Reddy's Laboratories, Inc.

  4. August 6, 2024 · Class II · Ongoing · D-0645-2024

    Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

    IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle. — Dr. Reddy's Laboratories, Inc.

  5. April 13, 2022 · Class II · Terminated · D-1055-2022

    cGMP deviations: Temperature abuse

    Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61 — Mckesson Medical-Surgical Inc. Corporate Office

  6. March 15, 2021 · Class II · Terminated · D-0437-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS) — Cardinal Health Inc.

  7. September 27, 2019 · Class II · Terminated · D-0298-2020

    Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

    Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 1 — Taro Pharmaceuticals U.S.A., Inc.

  8. September 27, 2019 · Class II · Terminated · D-0299-2020

    Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

    Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 105 — Taro Pharmaceuticals U.S.A., Inc.

  9. January 11, 2018 · Class II · Terminated · D-0687-2018

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., — Time-Cap Laboratories, Inc.

  10. January 11, 2018 · Class II · Terminated · D-0689-2018

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L — Time-Cap Laboratories, Inc.

  11. January 11, 2018 · Class II · Terminated · D-0692-2018

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., — Time-Cap Laboratories, Inc.

  12. January 9, 2018 · Class II · Terminated · D-0239-2018

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 — Marksans Pharma Inc.

  13. January 9, 2018 · Class II · Terminated · D-0240-2018

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 — Marksans Pharma Inc.

  14. January 9, 2018 · Class II · Terminated · D-0238-2018

    CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

    Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 — Marksans Pharma Inc.

  15. June 16, 2017 · Class II · Terminated · D-1055-2017

    Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.

    Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Ver — Time-Cap Laboratories, Inc.

  16. August 29, 2013 · Class II · Terminated · D-1042-2013

    Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

    IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA. — Dr. Reddy's Laboratories, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197803, 197804, 197805, 197806, 197807, 206905, 206913, 206917, 854183, 854187 … (+2)
SPL set ID of the quoted label1eaa7790-f1a1-4f51-b10a-cbbaf033f684
FDA labels (SPL)226
FDA applicationsNDA022348, 18 ANDA
Active ingredients (FDA)IBUPROFEN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Caldolor, Cumberland Pharmaceuticals Inc., effective January 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers