Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Childrens Ibuprofen Oral Suspension Dye Free (IBUPROFEN)
FSA Store Inc. (Caring Mill) · suspension · NDC 81522-311
Listed in the FDA National Drug Code directory
Childrens Ibuprofen Oral Suspension Dye Free is an over-the-counter medicine made available by FSA Store Inc. (Caring Mill), on the U.S. market since September 2025. It is marketed under an FDA approval (ANDA ANDA210602), 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 Sep 18, 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 Dye Free IBUPROFEN IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM ORIGINAL BERRY
Text on the package panel: Principal display panel list NDC 81522-311-11 †Compare to the active ingredient in Children's Motrin ® FOR AGES 2-11 YEARS CHILDREN'S IBUPROFEN 100 mg per 5 mL Oral Suspension, USP (NSAID) PAIN RELIEVER/FEVER REDUCER ORIGINAL Berry Flavor Dye-Free Alcohol-Free Lasts up to 8 HOURS 4 FL OZ (118mL) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children . †This product is not manufactured or distributed by McNeil C…
What it is for
Purpose Pain reliever/fever reducer
Key warnings
Warnings Allergy alert : Ibuprofen may cause 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 drug containing prescription or nonprescription NSAIDs (aspirin, …
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 81522-311. 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
Childrens Ibuprofen Oral Suspension Dye Free
Generic name
IBUPROFEN
Company
FSA Store Inc. (Caring Mill)
Form
suspension
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2026
Product NDC
81522-311
Active ingredients
Ibuprofen
100 mg/5mL
Packages (1)
The last part of the NDC identifies the pack size. Your box should show one of these.
81522-311-11 1 bottle in 1 carton (81522-311-11) / 118 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.