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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83840

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

Open FDA event record

Event summary

Timeline bucket
September 19, 2019
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Torrent Pharma 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

Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10

D-0121-2020
Recall number
D-0121-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
8,688 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-Methylnitrosobutyric acid (NMBA
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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Code information

Lot 4DU2E009

Distribution pattern

Nationwide USA and Puerto Rico

drug · product 2 of 4

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10

D-0122-2020
Recall number
D-0122-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
39,432 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-Methylnitrosobutyric acid (NMBA
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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Code information

Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021

Distribution pattern

Nationwide USA and Puerto Rico

drug · product 3 of 4

Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90

D-0123-2020
Recall number
D-0123-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
17,088 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-Methylnitrosobutyric acid (NMBA
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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Code information

Lot BEF7D051

Distribution pattern

Nationwide USA and Puerto Rico

drug · product 4 of 4

Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90

D-0124-2020
Recall number
D-0124-2020
Initiated
September 19, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
8,688 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity, N-Methylnitrosobutyric acid (NMBA
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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Code information

Lot 4P04D007

Distribution pattern

Nationwide USA and Puerto Rico