Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Ibuprofen (Ibuprofen)
St. Mary's Medical Park Pharmacy · tablet · NDC 60760-929
Listed in the FDA National Drug Code directory
Ibuprofen is a prescription medicine made available by St. Mary's Medical Park Pharmacy, on the U.S. market since January 2023. It is marketed under an FDA approval (ANDA ANDA213794), 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 Jul 7, 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 USP are available in the following strengths, colors and sizes: Ibuprofen Tablets USP, 800 mg are white to off-white, film-coated, capsule shaped tablets debossed with ‘I8’ on one side and plain on the other side. Bottles of 20 NDC 60760-929-20 Bottles of 30 NDC 60760-929-30 Bottles of 60 NDC 60760-929-60 Bottles of 90 NDC 60760-929-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40ºC (104ºF). Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides.
Product data on the label: Ibuprofen Ibuprofen SILICON DIOXIDE CROSCARMELLOSE SODIUM MICROCRYSTALLINE CELLULOSE 101 POLYETHYLENE GLYCOL 3350 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 STEARIC ACID TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN White to Off-white I8
Text on the package panel: PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg (100 Tablet Bottle) 929
What it is for
INDICATIONS AND USAGE 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.
Key warnings
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 gastrointestinal adverse events including bleeding, ulceration, and perfor…
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 60760-929. 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
St. Mary's Medical Park Pharmacy
Form
tablet
Route
oral
Type
HUMAN PRESCRIPTION DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
60760-929
Active ingredients
Ibuprofen
800 mg/1
Packages (4)
The last part of the NDC identifies the pack size. Your box should show one of these.
60760-929-20 20 tablet in 1 bottle, plastic (60760-929-20)
60760-929-30 30 tablet in 1 bottle, plastic (60760-929-30)
60760-929-60 60 tablet in 1 bottle, plastic (60760-929-60)
60760-929-90 90 tablet in 1 bottle, plastic (60760-929-90)
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 8, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.