cGMP deviations: Temperature abuse
Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61
Ibuprofen (Ibuprofen)
Major Pharmaceuticals · tablet · NDC 0904-5853
Listed in the FDA National Drug Code directory
1 recall on record
Ibuprofen is a prescription medicine made available by Major Pharmaceuticals, on the U.S. market since June 2009. It is marketed under an FDA approval (ANDA ANDA075682), so the FDA has reviewed its safety, effectiveness and manufacturing. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.
What the genuine product looks like
From the official FDA label (version of Aug 20, 2026). Compare the colour, shape, imprint and packaging with what you have. Any difference is a reason to ask a pharmacist before taking it.
HOW SUPPLIED Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg : Oval shaped, white, film-coated tablet debossed "4I" on one side. Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-5853-61 Bottles of 100 film-coated tablets, NDC 0904-5853-60 Bottles of 500 film-coated tablets, NDC 0904-5853-40 600 mg : Caplet shaped, white, film-coated tablet Debossed "6I" on one side. Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-5854-61 Bottles of 100 film-coated tablets, NDC 0904-5854-60 Bottles of 500 film-coated tablets, NDC 0904-5854-40 800 mg : Caplet shaped, white, film-coated tablet debossed "8I" on one side. Cartons of 100 film-coated tablets (10 film-coated tablets each blister pack x 10), NDC 0904-5855-61 Bottles of 100 film-coated tablets, NDC 0904-5855-60 Bottles of …
Product data on the label: Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE 4I Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE 6I Ibuprofen I…
Text on the package panel: Package/Label Display Panel MAJOR® NDC 0904-5853-61 Unit Dose Ibuprofen Tablets, USP 400 mg Pharmacist: Dispense with Medication Guide 100 TABLETS (10 x 10) Rx only 400mg carton label
What it is for
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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.
Key warnings
BOXED WARNING Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (See WARNINGS and PRECAUTIONS ). • Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (See CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Risk • NSAIDS cause an increased risk of serious gastrointestinaladverse events including bleeding, ul…
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
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Recalls of this product
Other recent recalls of ibuprofen
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
CGMP Deviations
Failed Tablet/Capsule Specifications
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Drug ineffective27,695 reports
Pain19,683 reports
Fatigue19,020 reports
Nausea18,574 reports
Headache16,765 reports
Arthralgia13,653 reports
Dyspnoea13,294 reports
Vomiting13,218 reports
Diarrhoea12,905 reports
Dizziness11,570 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 27,695 |
| Pain | 19,683 |
| Fatigue | 19,020 |
| Nausea | 18,574 |
| Headache | 16,765 |
| Arthralgia | 13,653 |
| Dyspnoea | 13,294 |
| Vomiting | 13,218 |
| Diarrhoea | 12,905 |
| Dizziness | 11,570 |
These counts are reports, not proof that the medicine caused the problem. Popular medicines get more reports simply because more people take them. They are useful for spotting what to watch for, not for comparing medicines.
Official listing
Brand
Ibuprofen
Generic name
Ibuprofen
Company
Major Pharmaceuticals
Form
tablet
Route
oral
Type
HUMAN PRESCRIPTION DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
0904-5853
Active ingredients
Ibuprofen
400 mg/1
Packages (3)
The last part of the NDC identifies the pack size. Your box should show one of these.
0904-5853-40 500 tablet in 1 bottle (0904-5853-40)
0904-5853-60 100 tablet in 1 bottle (0904-5853-60)
0904-5853-61 100 blister pack in 1 carton (0904-5853-61) / 1 tablet in 1 blister pack
Think your pack is fake?
Stop taking it, keep the pack and receipt, and show it to a pharmacist. In the U.S., report it to FDA MedWatch; elsewhere, to your national medicines regulator. How to spot a fake medicine.
Source: openFDA (U.S. Food and Drug Administration) drug directory, labels, enforcement reports and FAERS, retrieved Nov 9, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.