CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Ibuprofen Oral (Ibuprofen Oral)
NuCare Pharmaceuticals, Inc. · suspension · NDC 68071-5345
Listed in the FDA National Drug Code directory
Ibuprofen Oral is an over-the-counter medicine made available by NuCare Pharmaceuticals, Inc., on the U.S. market since September 2019. 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.
Advertisement
Recalls of this product
No FDA recalls are recorded for NDC 68071-5345. Recalls are listed in FDA enforcement reports from 2004 onward.
Other recent recalls of ibuprofen oral
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
Drug ineffective15,933 reports
Pain15,215 reports
Fatigue14,693 reports
Nausea13,725 reports
Headache12,242 reports
Arthralgia11,064 reports
Dyspnoea10,663 reports
Vomiting10,122 reports
Diarrhoea9,834 reports
Rash9,144 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 15,933 |
| Pain | 15,215 |
| Fatigue | 14,693 |
| Nausea | 13,725 |
| Headache | 12,242 |
| Arthralgia | 11,064 |
| Dyspnoea | 10,663 |
| Vomiting | 10,122 |
| Diarrhoea | 9,834 |
| Rash | 9,144 |
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 Oral
Generic name
Ibuprofen Oral
Company
NuCare Pharmaceuticals, Inc.
Form
suspension
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
68071-5345
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.
68071-5345-4 118 ml in 1 bottle (68071-5345-4)
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.