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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95778

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 18, 2024
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Endo USA, 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

4 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 4

Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).

D-0178-2025
Recall number
D-0178-2025
Initiated
November 18, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Endo USA, Inc.
Quantity
9,816 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. The blister strips inside the product carton reflect the correct strength.

Code information

Lot # 550176501, 550176601, Exp 02/28/2027.

Distribution pattern

Nationwide in the USA

drug · product 2 of 4

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).

D-0179-2025
Recall number
D-0179-2025
Initiated
November 18, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Endo USA, Inc.
Quantity
8,029 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. The blister strips inside the product carton reflect the correct strength.

Code information

Lot #: 550174101, Exp. 01/31/2027.

Distribution pattern

Nationwide in the USA

drug · product 3 of 4

Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).

D-0180-2025
Recall number
D-0180-2025
Initiated
November 18, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Endo USA, Inc.
Quantity
72,973 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. The blister strips inside the product carton reflect the correct strength.

Code information

Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.

Distribution pattern

Nationwide in the USA

drug · product 4 of 4

Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).

D-0181-2025
Recall number
D-0181-2025
Initiated
November 18, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Endo USA, Inc.
Quantity
22,513 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. The blister strips inside the product carton reflect the correct strength.

Code information

Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027

Distribution pattern

Nationwide in the USA