Exact FDA event identifier

Event 81707

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

Event summary

Timeline bucket: December 04, 2018
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Mylan Laboratories Limited, (Nashik FDF)

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

13 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 13

Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.

D-0320-2019

Recall number: D-0320-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 141,995 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 2 of 13

Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.

D-0321-2019

Recall number: D-0321-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 76,516 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot numbers: 3064085, 3066063,3069638,3069639

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 3 of 13

Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.

D-0322-2019

Recall number: D-0322-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 109,314 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 4 of 13

Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.

D-0323-2019

Recall number: D-0323-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 84,066 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 5 of 13

Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.

D-0324-2019

Recall number: D-0324-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 160,300 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers: 3063780, 3074879, 3086684, 3086687

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 6 of 13

Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.

D-0325-2019

Recall number: D-0325-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 119,761 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 7 of 13

Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.

D-0326-2019

Recall number: D-0326-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 232,180 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 8 of 13

Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.

D-0327-2019

Recall number: D-0327-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 129,754 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 9 of 13

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

D-0328-2019

Recall number: D-0328-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 32,696 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 10 of 13

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

D-0329-2019

Recall number: D-0329-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 50,595 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 11 of 13

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

D-0330-2019

Recall number: D-0330-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 22,813 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot numbers: 3084887 3093802 3084887 3084888 3093802

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 12 of 13

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

D-0331-2019

Recall number: D-0331-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 19,352 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot numbers: 3084889 3084890 3093803

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

drug · product 13 of 13

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.

D-0332-2019

Recall number: D-0332-2019
Initiated: December 04, 2018
Classification: Class II
Status: Ongoing
Recalling firm: Mylan Laboratories Limited, (Nashik FDF)
Quantity: 32,284 HDPE bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Code information

Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863

Distribution pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.