Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots, distribution and details
- Lots / codes
- Lot # HRSA17033-A, exp. date 10/2020 Lot # HRSA17034-A, exp. date 10/2020 Lot # HRSA17035-A, exp. date 10/2020 Lot # HRSA17036-A, exp. date 10/2020 Lot # HRSA17037-A, exp. date 10/2020
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 23,016 bottles
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0365-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots, distribution and details
- Lots / codes
- Lot # VKSA18005-A, exp. date 03/2020 Lot # VKSA18001-A, exp. date 01/2020
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 55,788 bottles
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0364-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots, distribution and details
- Lots / codes
- Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 27,688 bottles
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0363-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots, distribution and details
- Lots / codes
- Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. 01/2020 Lot # VFSA18007-A, exp. 03/2020 Lot # VFSA18008-A, exp. 03/2020 Lot # VKSA17008-A, exp. 05/2019 Lot # VFSA17009-A, exp. 10/2019 Lot # VKSA17014-A, exp. 10/2019 Lot # VKSA17015-A, exp. 10/2019 Lot # VKSA17016-A, exp. 10/2019 Lot # VKSA17017-A, exp. 10/2019 Lot # VKSA18002-A, exp. 01/2020 Lot # VKSA18004-A, exp. 01/2020
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 60,417 bottles
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0362-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots, distribution and details
- Product
- Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
- Lots / codes
- Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 18,408 bottles
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0361-2019
-
Class II Ongoing
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., Morgantow…
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 32,284 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0332-2019
-
Class II Ongoing
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., Morgant…
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot numbers: 3084889 3084890 3093803
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 19,352 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0331-2019
-
Class II Ongoing
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., Morgantow…
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot numbers: 3084887 3093802 3084887 3084888 3093802
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 22,813 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0330-2019
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Class II Ongoing
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., Morgant…
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 50,595 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0329-2019
-
Class II Ongoing
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., Morganto…
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 32,696 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0328-2019
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Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- 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
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 129,754 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0327-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 232,180 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0326-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 119,761 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0325-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 3063780, 3074879, 3086684, 3086687
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 160,300 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0324-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 84,066 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0323-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 109,314 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0322-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot numbers: 3064085, 3066063,3069638,3069639
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 76,516 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0321-2019
-
Class II Ongoing
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.
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- 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.
- Lots / codes
- Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Quantity
- 141,995 HDPE bottles
- Recall started
- December 4, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0320-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 48,302 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0318-2019
-
Class II Ongoing
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 5,660 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0317-2019
-
Class II Ongoing
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 25,147 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0316-2019
-
Class II Ongoing
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3061169, exp. date 11/2018
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 63,213 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0315-2019
-
Class II Ongoing
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3071352, exp. date 7/2019
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 12,840 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0314-2019
-
Class II Ongoing
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.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3063782, exp. date 1/2019
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 24,709 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0313-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot # 3079500, exp. date 1/2020
- Distribution
- Product was distributed throughout the United States.
- Quantity
- 12,336 bottles
- Recall started
- November 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0312-2019
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.