Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Good Neighbor Pharmacy Childrens Ibuprofen (Ibuprofen)
Amerisource Bergen · tablet, chewable · NDC 46122-617
Good Neighbor Pharmacy Childrens Ibuprofen is an over-the-counter medicine made available by Amerisource Bergen, on the U.S. market since July 2019. It is marketed under an FDA approval (ANDA ANDA076359), 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 28, 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: Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM AMMONIUM GLYCYRRHIZATE ASPARTAME CARNAUBA WAX CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL SILICON DIOXIDE SODIUM LAURYL SULFATE SOYBEAN OIL SUCCINIC ACID L461
Text on the package panel: Principal Display Panel GOOD NEIGHBOR PHARMACY ® Compare to Children’s Motrin ® active ingredient FOR AGES 2 TO 11 children’s Ibuprofen chewable tablets 100 mg Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Chewables Chew or crush tablets completely before swallowing actual size 24 Orange-Flavored Chewable Tablets good-neighbor-pharmacy-childrens-ibuprofen-orange-carton-image.jpg
What it is for
Purposes 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 nonprescriptio…
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
Recalls of this product
No FDA recalls are recorded for NDC 46122-617. 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.
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
Active ingredients
Packages (1)
The last part of the NDC identifies the pack size. Your box should show one of these.
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.