Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Ibuprofen (Ibuprofen)
Cardinal Health 107, LLC · tablet, film coated · NDC 55154-0669
Listed in the FDA National Drug Code directory
Ibuprofen is an over-the-counter medicine made available by Cardinal Health 107, LLC, on the U.S. market since June 2011. It is marketed under an FDA approval (ANDA ANDA075139), 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 May 19, 2026). Compare the colour, shape, imprint and packaging with what you have. Any difference is a reason to ask a pharmacist before taking it.
Product data on the label: Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN HYPROMELLOSE, UNSPECIFIED ANHYDROUS LACTOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TRIACETIN 44;438
Text on the package panel: Principal Display Panel NDC 55154-0669-0 IBUPROFEN TABLETS, USP 200mg Pain Reliever/Fever Reducer (NSAID) 10 TABLETS 200mg bag label
What it is for
Purpose Pain reliever/fever reducer
Key warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • rash • facial swelling • shock • blisters • skin reddening • hives • asthma (wheezing) If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • take more or for a longer time than directed • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • have 3 or more alcoholic drinks every day whi…
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
No FDA recalls are recorded for NDC 55154-0669. Recalls are listed in FDA enforcement reports from 2004 onward.
Other recent recalls of ibuprofen
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
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: Temperature abuse
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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
Cardinal Health 107, LLC
Form
tablet, film coated
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
55154-0669
Active ingredients
Ibuprofen
200 mg/1
Packages (1)
The last part of the NDC identifies the pack size. Your box should show one of these.
55154-0669-0 10 blister pack in 1 bag (55154-0669-0) / 1 tablet, film coated 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.