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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97797

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

Open FDA event record

Event summary

Timeline bucket
October 09, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Breckenridge Pharmaceutical, 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

Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.

D-0100-2026
Recall number
D-0100-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Quantity
172,263 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
N-nitroso-duloxetine 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: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Code information

90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026

Distribution pattern

U.S. Nationwide