Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Childrens Ibuprofen Oral Suspension (Ibuprofen)
PAI Holdings, LLC dba PAI Pharma · suspension · NDC 0121-0833
Listed in the FDA National Drug Code directory
Childrens Ibuprofen Oral Suspension is an over-the-counter medicine made available by PAI Holdings, LLC dba PAI Pharma, on the U.S. market since August 2025. It is marketed under an FDA approval (ANDA ANDA214789), 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 1, 2025). 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: Childrens Ibuprofen Oral Suspension Ibuprofen Ibuprofen Ibuprofen cellulose, microcrystalline anhydrous citric acid glycerin polysorbate 80 water sodium benzoate carboxymethylcellulose sodium, unspecified form sorbitol solution sucrose xanthan gum trisodium citrate dihydrate to off-white Childrens Ibuprofen Oral Suspension Ibuprofen Ibuprofen Ibuprofen cellulose, microcrystalline anhydrous citric acid glycerin polysorbate 80 water sodium benzoate carboxymethylcellulose sodium, unspecified form …
Text on the package panel: PRINCIPAL DISPLAY PANEL Delivers 5 mL NDC 0121- 0833 -05 CHILDREN'S IBUPROFEN ORAL SUSPENSION, USP (NSAID) 100 mg per 5 mL SHAKE WELL Alcohol Free/Dye Free For Institutional Use Only Dist. by : PAI Pharma Greenville, SC 29605 SEE DRUG FACTS Ibuprofen - 5 mL
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: hives facial swelling asthma (wheezing) shock skin reddening rash blisters 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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, i…
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 0121-0833. 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 ineffective27,693 reports
Pain19,680 reports
Fatigue19,019 reports
Nausea18,569 reports
Headache16,768 reports
Arthralgia13,653 reports
Dyspnoea13,291 reports
Vomiting13,216 reports
Diarrhoea12,902 reports
Dizziness11,570 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 27,693 |
| Pain | 19,680 |
| Fatigue | 19,019 |
| Nausea | 18,569 |
| Headache | 16,768 |
| Arthralgia | 13,653 |
| Dyspnoea | 13,291 |
| Vomiting | 13,216 |
| Diarrhoea | 12,902 |
| 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
Childrens Ibuprofen Oral Suspension
Generic name
Ibuprofen
Company
PAI Holdings, LLC dba PAI Pharma
Form
suspension
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
0121-0833
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.
0121-0833-00 10 tray in 1 case (0121-0833-00) / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0121-0833-05)
0121-0833-40 4 tray in 1 case (0121-0833-40) / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0121-0833-05)
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 10, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.