CLASS II Drug recall · Reported 10 Sep 2014 · FDA Enforcement Report
Oxycodone and Acetaminophen, USP 10 mg/325 mg, Cii recalled
Qualitest Pharmaceuticals is recalling Oxycodone and Acetaminophen, USP 10 mg/325 mg, Cii, distributed nationwide in the US. The recall was initiated on 27 Aug 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1572-2014
- FDA event ID
- 69157
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2014
- FDA classified
- 3 Sep 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 27 Aug 2014 | Recall initiated by company | |
| 3 Sep 2014 | Classified by FDA | +7 days |
| 10 Sep 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Which lots are affected?
T062A14A, Exp 12/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Oxycodone recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg recalledOxaydo | Zyla Life Sciences US | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |