NDC 72189-426
Oxycodone/APAP 10 mg / 325 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from SpecGx LLC's NDC 0406-0523.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| SpecGx LLC | Hobart, NY, United States | Makes it and tests it | No problems foundMar 13, 2020 · 6 inspections |
| SpecGx LLC | St. Louis, MO, United States | Makes the active ingredient | Problems found, fixed voluntarilyOct 22, 2025 · 8 inspections |
| SpecGx LLC | Greenville, IL, United States | Makes the active ingredient | Problems found, fixed voluntarilyFeb 27, 2026 · 5 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Dec 16, 2025 · Class II · SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Lots: Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027. - Dec 16, 2025 · Class II · SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Lots: Lot: 0522J23493, expires: 03/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetaminophen and Oxycodone: every company that makes it
- Form
- tablet
- Strength
- 10 mg / 325 mg
- Approval
- ANDA ANDA040545
- On the market since
- Feb 21, 2023
- Package NDCs
72189-426-3072189-426-6072189-426-7272189-426-90- Official label
- DailyMed (National Library of Medicine), updated Jul 24, 2023
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?