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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61791

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 07, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Endo Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-1381-2012
Recall number
D-1381-2012
Initiated
May 07, 2012
Classification
Class III
Status
Terminated
Quantity
11,764 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot #: 402794NV, Exp 12/13

Distribution pattern

Nationwide and Puerto Rico