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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94945

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

Open FDA event record

Event summary

Timeline bucket
July 10, 2024
Product types
Drug
Classifications
Class I
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

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

D-0622-2024
Recall number
D-0622-2024
Initiated
July 10, 2024
Classification
Class I
Status
Terminated
Quantity
8,139 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

Code information

Lot 550147301, Exp. 08/31/2026

Distribution pattern

Nationwide in the USA and Puerto Rico