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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96074

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

Open FDA event record

Event summary

Timeline bucket
December 30, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Rising Pharma Holding, 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

3 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 3

Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

D-0188-2025
Recall number
D-0188-2025
Initiated
December 30, 2024
Classification
Class II
Status
Ongoing
Quantity
42,527 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; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Code information

a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25

Distribution pattern

Nationwide

drug · product 2 of 3

Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

D-0189-2025
Recall number
D-0189-2025
Initiated
December 30, 2024
Classification
Class II
Status
Ongoing
Quantity
73,680 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; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Code information

Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25

Distribution pattern

Nationwide

drug · product 3 of 3

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

D-0190-2025
Recall number
D-0190-2025
Initiated
December 30, 2024
Classification
Class II
Status
Ongoing
Quantity
244,460 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; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Code information

Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25

Distribution pattern

Nationwide