CLASS III Drug recall · Reported 20 Jun 2012 · FDA Enforcement Report
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg recalled
Endo Pharmaceuticals is recalling Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/ per, distributed nationwide in the US. The recall was initiated on 7 May 2012 and the FDA has classified it as Class III.
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-1381-2012
- FDA event ID
- 61791
- Recalling firm
- Endo Pharmaceuticals, Chadds Ford, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 May 2012
- FDA classified
- 14 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 7 May 2012 | Recall initiated by company | |
| 14 Jun 2012 | Classified by FDA | +38 days |
| 20 Jun 2012 | 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
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Product as listed by the FDA
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Which lots are affected?
Lot #: 402794NV, Exp 12/13
Where was it sold?
Nationwide and Puerto Rico
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Endo Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | Calcitonin Salmon Nasal Spray recalled by Endo PharmaceuticalsCalcitonin Salmon | Endo Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | robaxin-750 (methocarbamol tablets, USP), 750 mg recalled | Endo Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex | Endo Pharmaceuticals | Sterility | Nationwide |