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)
Ibuprofen (Ibuprofen Oral)
Aurobindo Pharma Limited · suspension · NDC 59651-032
Listed in the FDA National Drug Code directory
1 recall on record
Ibuprofen is a prescription medicine made available by Aurobindo Pharma Limited, on the U.S. market since February 2018. It is marketed under an FDA approval (ANDA ANDA209178), 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 Mar 30, 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 oral suspension USP, 100 mg/5 mL is light orange to orange colored, berry flavored suspension. Bottles of 4 fl oz (120 mL) NDC 59651-032-12 Bottles of 16 fl oz (473 mL) NDC 59651-032-47 Shake well before using. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 08/2024 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
Product data on the label: Ibuprofen Ibuprofen Oral IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM RASPBERRY ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN HYPROMELLOSE 2208 (4000 MPA.S) POLYSORBATE 80 STARCH, POTATO WATER SODIUM BENZOATE SUCROSE XANTHAN GUM Light orange to orange
Text on the package panel: PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/5 mL - 4 FL OZ (120 mL) Bottle NDC 59651-032-12 Rx only Ibuprofen Oral Suspension USP 100 mg/5 mL PHARMACIST: Dispense the accompanying Medication Guide to each patient. 4 FL OZ (120 mL) AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/5 mL - 4 FL OZ (120 mL) Bottle
What it is for
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults, Ibuprofen Oral Suspension is indicated: For treatment of primary dysmenorrhea. For relief of the signs and sy…
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 oral suspension is 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…
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
Drug ineffective15,933 reports
Pain15,215 reports
Fatigue14,693 reports
Nausea13,725 reports
Headache12,242 reports
Arthralgia11,064 reports
Dyspnoea10,663 reports
Vomiting10,122 reports
Diarrhoea9,834 reports
Rash9,144 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 15,933 |
| Pain | 15,215 |
| Fatigue | 14,693 |
| Nausea | 13,725 |
| Headache | 12,242 |
| Arthralgia | 11,064 |
| Dyspnoea | 10,663 |
| Vomiting | 10,122 |
| Diarrhoea | 9,834 |
| Rash | 9,144 |
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 Oral
Company
Aurobindo Pharma Limited
Form
suspension
Route
oral
Type
HUMAN PRESCRIPTION DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
59651-032
Active ingredients
Ibuprofen
100 mg/5mL
Packages (2)
The last part of the NDC identifies the pack size. Your box should show one of these.
59651-032-12 1 bottle in 1 carton (59651-032-12) / 120 ml in 1 bottle
59651-032-47 1 bottle in 1 carton (59651-032-47) / 473 ml in 1 bottle
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.