CLASS II Drug recall · Reported 9 Oct 2013 · FDA Enforcement Report
Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled
Watson Laboratories is recalling Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, distributed nationwide in the US. The recall was initiated on 13 Sep 2013 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-66251-001
- FDA event ID
- 66251
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2013
- FDA classified
- 3 Oct 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 13 Sep 2013 | Recall initiated by company | |
| 3 Oct 2013 | Classified by FDA | +20 days |
| 9 Oct 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
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 Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Which lots are affected?
Lot #: 705791A, Exp 04/2015
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.
More recalls from Watson Laboratories
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories | Watson Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Next Choice" One Dose Emergency Contraceptive recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg recalled | Watson Laboratories | Potency & Assay | Nationwide |
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 |