Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Ibuprofen (Ibuprofen)
Strides Pharma Science Limited · suspension · NDC 64380-997
Listed in the FDA National Drug Code directory
Ibuprofen is a prescription medicine made available by Strides Pharma Science Limited, on the U.S. market since September 2023. It is marketed under an FDA approval (ANDA ANDA215311), 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 15, 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 Pale yellow to orange color suspension with mixed berry flavor -Carton containing bottle of 4 fl oz (118 mL) - NDC 64380-997-03 -Bottles of One Pint (473 mL) – NDC 64380-997-04 Shake well before using. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP. Manufactured by: Strides Pharma Science Limited Bengaluru – 562106, India Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807 Revised: 09/2025
Product data on the label: Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN GLYCERIN XANTHAN GUM SUCROSE SODIUM BENZOATE POLYSORBATE 80 ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED D&C YELLOW NO. 10 WATER
Text on the package panel: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC 64380-997-03 Ibuprofen Oral Suspension, USP 100 mg/5 mL Container label of 118 mL PHARMACIST: Dispense the accompanying Medication Guide to each patient. 118 Container
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. 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 symptoms of rheuma…
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
No FDA recalls are recorded for NDC 64380-997. 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
Strides Pharma Science Limited
Form
suspension
Route
oral
Type
HUMAN PRESCRIPTION DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
64380-997
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.
64380-997-03 1 bottle in 1 carton (64380-997-03) / 118 ml in 1 bottle
64380-997-04 473 ml in 1 bottle (64380-997-04)
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.