Ibuprofen
Tablet, Film Coated · Oral
Uses
Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.
Warnings
Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as Ibuprofen, increase the risk of serious gastrointestinal (GI) events [see WARNINGS ]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see CONTRAINDICATIONS ]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of Ibuprofen tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Ibuprofen tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension NSAIDs including Ibuprofen tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Ibuprofen tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of Ibuprofen may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] [See Drug Interactions ]. Avoid the use of Ibuprofen tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Ibuprofen tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure. Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation NSAIDs, including Ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients treated with neither of these risk factors.
Dosage and administration
Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. After observing the response to initial therapy with Ibuprofen Tablets, USP, the dose and frequency should be adjusted to suit an individual patient’s needs. Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer Ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease: Suggested Dosage: 1200 mg to 3200 mg daily (400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/ day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond. In general, patients with rheumatoid arthritis seem to require higher doses of Ibuprofen tablets than do patients with osteoarthritis. The smallest dose of Ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg [See CLINICAL PHARMACOLOGY for effects of food on rate of absorption]. The availability of three tablet strengths facilitates dosage adjustment. In chronic conditions, a therapeutic response to therapy with Ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient’s dose should be reviewed and adjusted as required. Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. In controlled analgesic clinical trials, doses of Ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose. Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, Ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
Label text from the FDA structured product label by AiPing Pharmaceutical, Inc. (revised Aug 11, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ibuprofen in 693 products
Ibuprofen NDC products (693)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7905 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5819 | Ibuprofen 400 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6645 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6676 | Ibuprofen 400 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6677 | Ibuprofen 400 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6886 | Ibuprofen 800 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7274 | Ibuprofen 100 mg/5mL Suspension | A-S Medication Solutions | ANDA |
| 50090-7281 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7282 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6616 | Ibuprofen 800 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7789 | Ibuprofen 400 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7788 | Ibuprofen 400 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7653 | Ibuprofen 100 mg/5mL Suspension | A-S Medication Solutions | ANDA |
| 50090-7321 | Ibuprofen 600 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7320 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7288 | Ibuprofen 600 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7283 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7286 | Ibuprofen 600 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-3007 | Ibuprofen 400 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2549 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2597 | Ibuprofen 800 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2625 | Ibuprofen 600 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2626 | Ibuprofen 600 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2629 | Ibuprofen 600 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5223 | Ibuprofen 200 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5433 | Ibuprofen 600 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5435 | Ibuprofen 600 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5444 | Ibuprofen 800 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5445 | Ibuprofen 800 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5446 | Ibuprofen 800 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5818 | Ibuprofen 400 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 57344-109 | Ibuprofen 200 mg/1 Tablet, Coated | AAA Pharmaceutical, Inc. | ANDA |
| 57344-110 | Ibuprofen 200 mg/1 Tablet, Coated | AAA Pharmaceutical, Inc. | ANDA |
| 57344-309 | Ibuprofen 200 mg/1 Tablet, Coated | AAA Pharmaceutical, Inc. | ANDA |
| 57344-811 | Ibuprofen 200 mg/1 Tablet, Coated | AAA Pharmaceutical, Inc. | ANDA |
| 55301-745 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | AAFES/Your Military Exchanges | ANDA |
| 0472-2002 | Ibuprofen 100 mg/5mL Suspension | Actavis Pharma, Inc. | ANDA |
| 67060-001 | Ibuprofen 200 mg/1 Tablet, Film Coated | ADVANCED FIRST AID, INC. | ANDA |
| 80425-0426 | Ibuprofen 600 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0393 | Ibuprofen 800 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0537 | Ibuprofen 800 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0553 | Ibuprofen 600 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0047 | Ibuprofen 800 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0046 | Ibuprofen 800 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0089 | Ibuprofen 800 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0424 | Ibuprofen 600 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0132 | Ibuprofen 600 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0154 | Ibuprofen 600 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0243 | Ibuprofen 800 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 11788-009 | Ibuprofen 600 mg/1 Tablet, Film Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-010 | Ibuprofen 800 mg/1 Tablet, Film Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-008 | Ibuprofen 400 mg/1 Tablet, Film Coated | AiPing Pharmaceutical, Inc. | ANDA |
| 69168-466 | Ibuprofen 200 mg/1 Tablet, Film Coated | Allegiant Health | ANDA |
| 69168-335 | Ibuprofen 200 mg/1 Tablet | Allegiant Health | ANDA |
| 72288-080 | Ibuprofen 200 mg/1 Tablet, Film Coated | Amazon.com Services LLC | ANDA |
| 72288-640 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Amazon.com Services LLC | ANDA |
| 72288-143 | Ibuprofen 200 mg/1 Tablet, Film Coated | Amazon.com Services LLC | ANDA |
| 60687-457 | Ibuprofen 600 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-446 | Ibuprofen 400 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-468 | Ibuprofen 800 mg/1 Tablet | American Health Packaging | ANDA |
| 61504-185 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | AMERIFOODS TRADING COMPANY | ANDA |
| 61504-110 | Ibuprofen 200 mg/1 Tablet, Coated | AMERIFOODS TRADING COMPANY | ANDA |
| 61504-109 | Ibuprofen 200 mg/1 Tablet, Coated | AMERIFOODS TRADING COMPANY | ANDA |
| 46122-580 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | AMERISOURCE BERGEN | ANDA |
| 46122-593 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | AMERISOURCE BERGEN | ANDA |
| 65162-356 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Amneal Pharmaceuticals LLC | ANDA |
| 65162-464 | Ibuprofen 400 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-465 | Ibuprofen 600 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 65162-466 | Ibuprofen 800 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA |
| 69238-1103 | Ibuprofen 800 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1102 | Ibuprofen 600 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1101 | Ibuprofen 400 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 53746-464 | Ibuprofen 400 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-131 | Ibuprofen 400 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-132 | Ibuprofen 600 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-137 | Ibuprofen 800 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-466 | Ibuprofen 800 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-140 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-142 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-462 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-465 | Ibuprofen 600 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-460 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-458 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-144 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 53746-143 | Ibuprofen 200 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 71610-969 | Ibuprofen 400 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-968 | Ibuprofen 600 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-222 | Ibuprofen 600 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-532 | Ibuprofen 600 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-629 | Ibuprofen 600 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-901 | Ibuprofen 800 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-967 | Ibuprofen 800 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-890 | Ibuprofen 800 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-891 | Ibuprofen 600 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-892 | Ibuprofen 800 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-895 | Ibuprofen 600 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-897 | Ibuprofen 800 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-898 | Ibuprofen 800 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-916 | Ibuprofen 400 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-902 | Ibuprofen 600 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 55301-292 | Ibuprofen 200 mg/1 Tablet, Film Coated | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA |
| 55301-393 | Ibuprofen 200 mg/1 Tablet, Film Coated | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA |
| 55301-392 | Ibuprofen 200 mg/1 Tablet, Film Coated | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA |
| 55301-291 | Ibuprofen 200 mg/1 Tablet, Film Coated | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA |
| 67877-739 | Ibuprofen 800 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-738 | Ibuprofen 600 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-737 | Ibuprofen 400 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-321 | Ibuprofen 800 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-320 | Ibuprofen 600 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-319 | Ibuprofen 400 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 76420-847 | Ibuprofen 600 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-846 | Ibuprofen 400 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-577 | Ibuprofen 800 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-848 | Ibuprofen 800 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-415 | Ibuprofen 800 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-575 | Ibuprofen 400 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-576 | Ibuprofen 600 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 17856-5309 | Ibuprofen 100 mg/5mL Suspension | ATLANTIC BIOLOGICALS CORP. | ANDA |
| 17856-5310 | Ibuprofen 100 mg/5mL Suspension | ATLANTIC BIOLOGICALS CORP. | ANDA |
| 59651-032 | Ibuprofen 100 mg/5mL Suspension | Aurobindo Pharma Limited | ANDA |
| 59651-360 | Ibuprofen 400 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-361 | Ibuprofen 600 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-362 | Ibuprofen 800 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 58602-713 | Ibuprofen 200 mg/1 Tablet | Aurohealth LLC | ANDA |
| 58602-852 | Ibuprofen 200 mg/1 Capsule | Aurohealth LLC | ANDA |
| 58602-708 | Ibuprofen 200 mg/1 Tablet | Aurohealth LLC | ANDA |
| 58602-843 | Ibuprofen 200 mg/1 Capsule | Aurohealth LLC | ANDA |
| 58602-902 | Ibuprofen 200 mg/1 Capsule | Aurohealth LLC | ANDA |
| 58602-879 | Ibuprofen 200 mg/1 Capsule | Aurohealth LLC | ANDA |
| 58602-802 | Ibuprofen 200 mg/1 Tablet | Aurohealth LLC | ANDA |
| 58602-801 | Ibuprofen 200 mg/1 Tablet | Aurohealth LLC | ANDA |
| 0761-0908 | Ibuprofen 200 mg/1 Tablet | Basic Drugs, Inc. | ANDA |
| 63941-745 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Best Choice (Valu Merchandisers Company) | ANDA |
| 21130-032 | Ibuprofen 200 mg/1 Capsule | Better Living Brands LLC | ANDA |
| 21130-396 | Ibuprofen 200 mg/1 Tablet | BETTER LIVING BRANDS LLC. | ANDA |
| 21130-359 | Ibuprofen 200 mg/1 Tablet, Coated | BETTER LIVING BRANDS LLC. | ANDA |
| 21130-358 | Ibuprofen 200 mg/1 Tablet, Coated | BETTER LIVING BRANDS LLC. | ANDA |
| 21130-393 | Ibuprofen 200 mg/1 Tablet, Film Coated | Better Living Brands, LLC | ANDA |
| 21130-361 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | BETTER LIVING BRANDS, LLC | ANDA |
| 21130-261 | Ibuprofen 200 mg/1 Tablet | BETTER LIVING BRANDS, LLC | ANDA |
| 21130-070 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | BETTER LIVING BRANDS, LLC | ANDA |
| 21130-992 | Ibuprofen 200 mg/1 Tablet | BETTER LIVING BRANDS, LLC | ANDA |
| 21130-006 | Ibuprofen 200 mg/1 Tablet | BETTER LIVING BRANDS, LLC | ANDA |
| 37835-585 | Ibuprofen 200 mg/1 Tablet | BI-MART | ANDA |
| 37835-588 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Bi-Mart | ANDA |
| 37835-581 | Ibuprofen 200 mg/1 Tablet | Bi-Mart | ANDA |
| 69452-239 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Bionpharma Inc. | ANDA |
| 69452-305 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Bionpharma Inc. | ANDA |
| 69452-212 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Bionpharma Inc. | ANDA |
| 68391-212 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | BJWC | ANDA |
| 68391-610 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | BJWC (Berkley & Jensen / BJ's) | ANDA |
| 83209-464 | Ibuprofen 400 mg/1 Tablet | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA |
| 70729-291 | Ibuprofen 200 mg/1 Tablet, Film Coated | Breeden Brothers, LLC | ANDA |
| 73614-201 | Ibuprofen 800 mg/1 Tablet, Film Coated | Brisk Pharmaceuticals | ANDA |
| 71335-0690 | Ibuprofen 400 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1206 | Ibuprofen 800 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1073 | Ibuprofen 800 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-7676 | Ibuprofen 400 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-1470 | Ibuprofen 800 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-1467 | Ibuprofen 200 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1207 | Ibuprofen 600 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1218 | Ibuprofen 600 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1270 | Ibuprofen 400 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2341 | Ibuprofen 100 mg/5mL Suspension | Bryant Ranch Prepack | ANDA |
| 71335-1396 | Ibuprofen 800 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1503 | Ibuprofen 600 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 83615-0001 | Ibuprofen 600 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1517 | Ibuprofen 400 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1911 | Ibuprofen 200 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2068 | Ibuprofen 200 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2682 | Ibuprofen 400 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2683 | Ibuprofen 600 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2689 | Ibuprofen 800 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-3108 | Ibuprofen 800 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-3121 | Ibuprofen 600 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-1468 | Ibuprofen 400 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 70000-0597 | Ibuprofen 200 mg/1 Tablet | CARDINAL HEALTH | ANDA |
| 70000-0571 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Cardinal Health (Leader) 70000 | ANDA |
| 55154-2583 | Ibuprofen 400 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-1380 | Ibuprofen 400 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-1342 | Ibuprofen 800 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-0741 | Ibuprofen 600 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-0669 | Ibuprofen 200 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 70000-0291 | Ibuprofen 200 mg/1 Tablet, Film Coated | Cardinal Health 110, LLC. DBA Leader | ANDA |
| 41520-745 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Care One (American Sales Company) | ANDA |
| 72476-745 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Care One (Retail Business Services, LLC.) | ANDA |
| 68016-634 | Ibuprofen 200 mg/1 Tablet, Film Coated | Chain Drug Consortium | ANDA |
| 68016-813 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Chain Drug Consortium, LLC | ANDA |
| 63868-979 | Ibuprofen 200 mg/1 Tablet, Film Coated | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA |
| 63868-773 | Ibuprofen 200 mg/1 Tablet, Film Coated | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA |
| 63868-571 | Ibuprofen 200 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA |
| 63868-570 | Ibuprofen 200 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA |
| 63868-428 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA |
| 63868-268 | Ibuprofen 200 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA |
| 63868-427 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA |
| 83324-203 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA |
| 83324-210 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA |
| 83324-056 | Ibuprofen 200 mg/1 Tablet, Film Coated | Chain Drug Marketing Association, Inc. | ANDA |
| 83324-101 | Ibuprofen 200 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION, INC. | ANDA |
| 83324-102 | Ibuprofen 200 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION, INC. | ANDA |
| 83324-206 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Chain Drug Marketing Association, Inc. | ANDA |
| 83324-207 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Chain Drug Marketing Association, Inc. | ANDA |
| 83324-100 | Ibuprofen 200 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION, INC. | ANDA |
| 83324-059 | Ibuprofen 200 mg/1 Tablet, Film Coated | Chain Drug Marketing Association, Inc. | ANDA |
| 63868-470 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Chain Drug Marketing Association, Inc. | ANDA |
| 62135-400 | Ibuprofen 400 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-401 | Ibuprofen 600 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-402 | Ibuprofen 800 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 10267-3846 | Ibuprofen 200 mg/1 Tablet | Contract Pharmacal Corp. | ANDA |
| 10267-3852 | Ibuprofen 200 mg/1 Tablet | Contract Pharmacal Corp. | ANDA |
| 10267-3909 | Ibuprofen 200 mg/1 Tablet | Contract Pharmacal Corp. | ANDA |
| 63981-750 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Costco Wholesale | ANDA |
| 63981-598 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Costco Wholesale | ANDA |
| 63981-291 | Ibuprofen 200 mg/1 Tablet, Film Coated | COSTCO WHOLESALE CORPORATION | ANDA |
| 63981-393 | Ibuprofen 200 mg/1 Tablet, Film Coated | COSTCO WHOLESALE CORPORATION | ANDA |
| 67046-1214 | Ibuprofen 800 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1606 | Ibuprofen 800 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1646 | Ibuprofen 600 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 51316-365 | Ibuprofen 200 mg/1 Tablet | CVS | ANDA |
| 59779-660 | Ibuprofen 100 mg/5mL Suspension | CVS Pharmacy | ANDA |
| 59779-897 | Ibuprofen 100 mg/5mL Suspension | CVS Pharmacy | ANDA |
| 69842-649 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | CVS Pharmacy | ANDA |
| 59779-166 | Ibuprofen 100 mg/5mL Suspension | CVS Pharmacy | ANDA |
| 59779-685 | Ibuprofen 100 mg/5mL Suspension | CVS Pharmacy | ANDA |
| 59779-647 | Ibuprofen 200 mg/1 Tablet, Film Coated | CVS Pharmacy | ANDA |
| 69842-745 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | CVS Pharmacy | ANDA |
| 59779-604 | Ibuprofen 200 mg/1 Tablet, Film Coated | CVS Pharmacy | ANDA |
| 59779-517 | Ibuprofen 200 mg/1 Tablet, Film Coated | CVS Pharmacy | ANDA |
| 59779-438 | Ibuprofen 200 mg/1 Tablet, Film Coated | CVS Pharmacy | ANDA |
| 59779-313 | Ibuprofen 50 mg/1.25mL Suspension/ Drops | CVS Pharmacy | ANDA |
| 59779-291 | Ibuprofen 200 mg/1 Tablet, Film Coated | CVS Pharmacy | ANDA |
| 69842-391 | Ibuprofen 200 mg/1 Tablet | CVS PHARMACY, INC. | ANDA |
| 69842-493 | Ibuprofen 200 mg/1 Tablet | CVS Pharmacy. Inc. | ANDA |
| 69842-489 | Ibuprofen 200 mg/1 Tablet, Coated | CVS Pharmacy.Inc. | ANDA |
| 53942-112 | Ibuprofen 200 mg/1 Tablet, Coated | Demoulas Super Markets, Inc | ANDA |
| 72189-231 | Ibuprofen 600 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 72189-266 | Ibuprofen 800 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 72189-324 | Ibuprofen 400 mg/1 Tablet, Film Coated | Direct Rx | ANDA |
| 61919-463 | Ibuprofen 800 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-564 | Ibuprofen 400 mg/1 Tablet | Direct_rx | ANDA |
| 72189-643 | Ibuprofen 600 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-556 | Ibuprofen 800 mg/1 Tablet | Direct_Rx | ANDA |
| 53943-292 | Ibuprofen 200 mg/1 Tablet, Film Coated | Discount Drug Mart | ANDA |
| 53943-291 | Ibuprofen 200 mg/1 Tablet, Film Coated | Discount Drug Mart | ANDA |
| 53943-112 | Ibuprofen 200 mg/1 Tablet, Coated | DISCOUNT DRUG MART | ANDA |
| 53943-111 | Ibuprofen 200 mg/1 Tablet, Coated | DISCOUNT DRUG MART | ANDA |
| 53943-214 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | DISCOUNT DRUG MART, INC. | ANDA |
| 53943-212 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | DISCOUNT DRUG MART, INC. | ANDA |
| 55910-518 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | DOLGENCORP INC | ANDA |
| 55910-901 | Ibuprofen 200 mg/1 Tablet, Coated | DOLGENCORP INC | ANDA |
| 55910-399 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | DOLGENCORP, INC. | ANDA |
| 55910-847 | Ibuprofen 200 mg/1 Tablet, Film Coated | Dolgencorp, Inc. | ANDA |
| 55910-046 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 55910-845 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 55910-830 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 55910-768 | Ibuprofen 200 mg/1 Tablet, Coated | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 55910-741 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 55910-197 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA |
| 55910-791 | Ibuprofen 200 mg/1 Tablet, Film Coated | DOLGENCORP, LLC | ANDA |
| 75907-428 | Ibuprofen 200 mg/1 Tablet, Coated | Dr. Reddy's Laboratories Inc. | ANDA |
| 49035-693 | Ibuprofen 100 mg/5mL Suspension | EQUATE (WAL-MART STORES, INC.) | ANDA |
| 76282-714 | Ibuprofen 800 mg/1 Tablet, Film Coated | EXELAN PHARMACEUTICALS, INC. | ANDA |
| 76282-713 | Ibuprofen 600 mg/1 Tablet, Film Coated | EXELAN PHARMACEUTICALS, INC. | ANDA |
| 76282-712 | Ibuprofen 400 mg/1 Tablet, Film Coated | EXELAN PHARMACEUTICALS, INC. | ANDA |
| 55319-366 | Ibuprofen 200 mg/1 Tablet | Family Dollar | ANDA |
| 55319-252 | Ibuprofen 200 mg/1 Tablet, Coated | Family Dollar (FAMILY WELLNESS) | ANDA |
| 55319-136 | Ibuprofen 200 mg/1 Tablet, Coated | Family Dollar (FAMILY WELLNESS) | ANDA |
| 55319-137 | Ibuprofen 200 mg/1 Tablet, Coated | Family Dollar (FAMILY WELLNESS) | ANDA |
| 55319-552 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Family Dollar (FAMILY WELLNESS) | ANDA |
| 55319-893 | Ibuprofen 200 mg/1 Tablet, Film Coated | Family Dollar Services Inc | ANDA |
| 71921-180 | Ibuprofen 400 mg/1 Tablet, Film Coated | Florida Pharmaceutical Products, LLC | ANDA |
| 71921-181 | Ibuprofen 600 mg/1 Tablet, Film Coated | Florida Pharmaceutical Products, LLC | ANDA |
| 71921-182 | Ibuprofen 800 mg/1 Tablet, Film Coated | Florida Pharmaceutical Products, LLC | ANDA |
| 81522-119 | Ibuprofen 200 mg/1 Tablet, Coated | FSA STORE INC. | ANDA |
| 81522-185 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | FSA STORE INC. | ANDA |
| 57896-941 | Ibuprofen 200 mg/1 Tablet, Film Coated | Geri-Care Pharmaceutical Corp | ANDA |
| 54162-941 | Ibuprofen 200 mg/1 Tablet, Coated | Geritrex LLC | ANDA |
| 82501-1010 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | Gobrands, Inc. (Goodnow) | ANDA |
| 51407-841 | Ibuprofen 800 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-839 | Ibuprofen 400 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-840 | Ibuprofen 600 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 50804-185 | Ibuprofen 200 mg/1 Capsule, Liquid Filled | GOODSENSE | ANDA |
| 62207-354 | Ibuprofen 400 mg/1 Tablet, Film Coated | Granules India Limited | ANDA |
| 62207-320 | Ibuprofen 200 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-321 | Ibuprofen 200 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-355 | Ibuprofen 600 mg/1 Tablet, Film Coated | Granules India Limited | ANDA |
| 62207-396 | Ibuprofen 200 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-395 | Ibuprofen 200 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-366 | Ibuprofen 200 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-365 | Ibuprofen 200 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-356 | Ibuprofen 800 mg/1 Tablet, Film Coated | Granules India Limited | ANDA |
| 70010-067 | Ibuprofen 600 mg/1 Tablet, Film Coated | Granules Pharmaceuticals Inc. | ANDA |
| 70010-068 | Ibuprofen 800 mg/1 Tablet, Film Coated | Granules Pharmaceuticals Inc. | ANDA |
| 70010-066 | Ibuprofen 400 mg/1 Tablet, Film Coated | Granules Pharmaceuticals Inc. | ANDA |
| 69848-012 | Ibuprofen 200 mg/1 Tablet | Granules USA, Inc. | ANDA |
| 69848-011 | Ibuprofen 200 mg/1 Tablet | Granules USA, Inc. | ANDA |
| 85828-601 | Ibuprofen 200 mg/1 Tablet, Coated | Grocery Outlet, Inc. | ANDA |
| 85828-110 | Ibuprofen 200 mg/1 Tablet, Coated | Grocery Outlet, Inc. | ANDA |
| 37808-363 | Ibuprofen 100 mg/5mL Suspension | H E B | ANDA |
| 37808-393 | Ibuprofen 200 mg/1 Tablet, Film Coated | H E B | ANDA |
Ibuprofen recalls
- D-0390-2026 Mar 25, 2026 · Class II · Ongoing
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. - D-1055-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse - D-0437-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0298-2020 Nov 6, 2019 · Class II · Terminated
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - D-0299-2020 Nov 6, 2019 · Class II · Terminated
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - D-0300-2020 Nov 6, 2019 · Class II · Terminated
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - D-0301-2020 Nov 6, 2019 · Class II · Terminated
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. - D-0685-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0695-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0694-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0692-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0689-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0687-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0686-2018 May 2, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0235-2018 Jan 31, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-0237-2018 Jan 31, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. - D-1055-2017 Aug 9, 2017 · Class II · Terminated
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Frequently asked questions
What is Ibuprofen used for?
Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are…
Who makes Ibuprofen?
Ibuprofen is listed by 91 labelers in the FDA NDC directory, including A-S Medication Solutions, AAA Pharmaceutical, Inc., AAFES/Your Military Exchanges, Actavis Pharma, Inc..
Has Ibuprofen been recalled?
The FDA enforcement database lists 17 recalls for Ibuprofen, most recently D-0390-2026 (class ii): Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.