Quick answers
- What is Oxycodone and acetaminophen used for?
- The FDA-approved label (Endocet, Par Health USA, LLC, December 1, 2025) says: “ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxycodone and acetaminophen have a boxed warning?
- Yes. The FDA label for Endocet has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ENDOCET”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oxycodone and acetaminophen?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 3, 2025). Ask your pharmacist about alternatives.
- Has Oxycodone and acetaminophen been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started December 16, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Oxycodone and acetaminophen?
- 28 companies list prescription products of Oxycodone and acetaminophen in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Asclemed USA, Inc..
What Oxycodone and acetaminophen is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment …
— FDA label: Endocet, Par Health USA, LLC, effective December 1, 2025. Read the full label on DailyMed →
The FDA has 76 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ENDOCET
. Read it on the full label →
73 of 76 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetaminophen 325 mg · oxycodone 10 mg tablet | Generic | $0.2300 per tablet |
| acetaminophen 325 mg · oxycodone 2.5 mg tablet | Generic | $0.8394 per tablet |
| acetaminophen 325 mg · oxycodone 5 mg tablet | Generic | $0.1178 per tablet |
| acetaminophen 325 mg · oxycodone 7.5 mg tablet | Generic | $0.1828 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 10 mg tablet | Generic | $0.2300 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 10 mg tablet | Brand: Percocet | $41.39 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 2.5 mg tablet | Generic | $0.8394 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 5 mg tablet | Generic | $0.1178 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 5 mg tablet | Brand: Percocet | $29.32 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 7.5 mg tablet | Generic | $0.1828 per tablet |
| acetaminophen 325 mg · oxycodone hydrochloride 7.5 mg tablet | Brand: Percocet | $31.58 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack24 products
- Proficient Rx LP9 products
- Asclemed USA, Inc.9 products
- Camber Pharmaceuticals, Inc.8 products
- St. Mary's Medical Park Pharmacy6 products
- Direct_Rx6 products
- SpecGx LLC6 products
- Forte Bio-Pharma LLC5 products
- FH2 Pharma LLC5 products
- KVK-Tech, Inc.5 products
- XLCare Pharmaceuticals, Inc.4 products
- Aurolife Pharma, LLC4 products
- Par Health USA, LLC4 products
- Lupin Pharmaceuticals, Inc.4 products
- Granules Pharmaceuticals Inc.4 products
- Eywa Pharma Inc3 products
- Rhodes Pharmaceuticals LLC3 products
- Alvogen Inc.3 products
- Major Pharmaceuticals3 products
- AvPAK3 products
- American Health Packaging3 products
- Elite Laboratories, Inc.3 products
- Epic Pharma, LLC3 products
- NuCare Pharmaceuticals, Inc.3 products
- Redpharm Drug2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Amneal Pharmaceuticals LLC1 product
- Quality Care Products, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (18)
- ANDA087463Specgx LLC · December 7, 1983
- ANDA040330Ozantri · June 25, 1999
- ANDA040545Specgx LLC · June 30, 2004
- ANDA040608Pharmobedient · December 30, 2005
- ANDA040777Amneal Pharms · November 27, 2007
- ANDA040778Amneal Pharms Ny · November 27, 2007
- ANDA202677Alvogen · July 26, 2012
- ANDA201972Aurolife Pharma LLC · July 15, 2013
- ANDA201278Rhodes Pharms · August 28, 2014
- ANDA204407Novel Labs Inc · February 24, 2017
- ANDA207419Ascent Pharms Inc · March 22, 2017
- ANDA210644Abhai LLC · February 9, 2018
- ANDA207510Wes Pharma Inc · March 21, 2018
- ANDA203864Epic Pharma LLC · July 2, 2018
- ANDA209385Elite Labs Inc · July 2, 2018
- ANDA202142Pharmobedient · November 27, 2018
- ANDA211499Abhai LLC · December 31, 2018
- ANDA211708Granules · October 31, 2019
Shortage status
To be discontinued · updated November 3, 2025 · first posted November 3, 2025
| Product | Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 7.5 mg (NDC 60951-700-70) |
|---|---|
| Company | Endo Pharmaceuticals, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 16, 2025 · Class II · Ongoing · D-0254-2026
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. — SpecGx, LLC
-
December 16, 2025 · Class II · Ongoing · D-0255-2026
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — SpecGx, LLC
-
March 18, 2020 · Class II · Terminated · D-1237-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01 — Aurobindo Pharma USA Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Endocet, Par Health USA, LLC, effective December 1, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →