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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95896

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

Open FDA event record

Event summary

Timeline bucket
December 12, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ascend Laboratories, LLC

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

2 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 2

Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

D-0129-2025
Recall number
D-0129-2025
Initiated
December 12, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
1971 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Dabigatran impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Code information

Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

D-0130-2025
Recall number
D-0130-2025
Initiated
December 12, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
10,444 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-Dabigatran impurity
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Code information

Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;

Distribution pattern

Nationwide within the United States