Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Ibuprofen (IBUPROFEN)
Shandong Xinhua Pharmaceutical Company Limited · powder · NDC 58624-0050
Listed in the FDA National Drug Code directory
Ibuprofen is a bulk ingredient (not a finished medicine) made available by Shandong Xinhua Pharmaceutical Company Limited, on the U.S. market since January 1987. Its listing category is "BULK INGREDIENT". Listing is not the same as FDA approval. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.
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Recalls of this product
No FDA recalls are recorded for NDC 58624-0050. 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
Shandong Xinhua Pharmaceutical Company Limited
Form
powder
Route
—
Type
BULK INGREDIENT
Category
BULK INGREDIENT
Listing valid to
Dec 31, 2026
Product NDC
58624-0050
Active ingredients
Ibuprofen
1 kg/kg
Packages (1)
The last part of the NDC identifies the pack size. Your box should show one of these.
58624-0050-0 25 kg in 1 drum (58624-0050-0)
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.