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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80847

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

Open FDA event record

Event summary

Timeline bucket
August 17, 2018
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

12 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 12

Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90

D-1134-2018
Recall number
D-1134-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
24468 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, BV46C006

Distribution pattern

Nationwide USA

drug · product 2 of 12

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

D-1135-2018
Recall number
D-1135-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
14016 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004

Distribution pattern

Nationwide USA

drug · product 3 of 12

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

D-1136-2018
Recall number
D-1136-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
ALL

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV48D001, BV48D002

Distribution pattern

Nationwide USA

drug · product 4 of 12

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30

D-1137-2018
Recall number
D-1137-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
89616 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010

Distribution pattern

Nationwide USA

drug · product 5 of 12

Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30

D-1138-2018
Recall number
D-1138-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
66864 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009

Distribution pattern

Nationwide USA

drug · product 6 of 12

Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30

D-1139-2018
Recall number
D-1139-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
46272 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001

Distribution pattern

Nationwide USA

drug · product 7 of 12

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30

D-1140-2018
Recall number
D-1140-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
78144 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005

Distribution pattern

Nationwide USA

drug · product 8 of 12

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30

D-1141-2018
Recall number
D-1141-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
169,200 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007

Distribution pattern

Nationwide USA

drug · product 9 of 12

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30

D-1142-2018
Recall number
D-1142-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
50,784 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001

Distribution pattern

Nationwide USA

drug · product 10 of 12

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

D-1143-2018
Recall number
D-1143-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
22704 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BBY2E001, BBY2D001, BBY2D002

Distribution pattern

Nationwide USA

drug · product 11 of 12

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

D-1144-2018
Recall number
D-1144-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
34320 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003

Distribution pattern

Nationwide USA

drug · product 12 of 12

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30

D-1145-2018
Recall number
D-1145-2018
Initiated
August 17, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Torrent Pharma Inc.
Quantity
37704 bottles

App-derived interpretation

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: Carcinogen impurity detected in API used to manufacture drug product.

Code information

Batch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003

Distribution pattern

Nationwide USA