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 Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 — NDC 52343-125-90
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Lots / codes
- 473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 42,016 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1055-2019
-
Class II Ongoing
Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 —- NDC 52343-124-90
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Lots / codes
- 472180005B, exp. date 02/29/2020 472180011A, exp. date 04/30/2020 472180012A, exp. date 04/30/2020
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 35,281 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1054-2019
-
Class II Ongoing
Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 — NDC 52343-123-90
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Product
- Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 — NDC 52343-123-90
- Lots / codes
- 471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 37,410 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1053-2019
-
Class II Ongoing
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ —- NDC 52343-122-30
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Product
- Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ —- NDC 52343-122-30
- Lots / codes
- 470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 30,530 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1052-2019
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Class II Ongoing
Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutica…
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54
- Lots / codes
- 180886, Nov-19; 180887, 180888, 180905, Dec-19; 181123, Sep-2019; 181124, Oct-2019, 181125, Aug-19, 181351, Nov-19, 181352, Dec-19, 181551, Nov-19, 181628, 181629, 181727, 181728, Jun-20; 181890, Mar-20; 181891, 181897, Jun-20; 182114, Mar-20; 182119, 182120, Jun-20
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Quantity
- 2,497,856 bottles
- Recall started
- March 1, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1050-2019
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Class II Ongoing
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical…
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
- Lots / codes
- Lots: 180921, exp Sep-19, 180922, exp Oct-19, 180923, 180924, 181118, exp Nov-19, 181119, exp Oct-19, 181407, exp Nov-19, 181408, exp Dec-19, 181573, 181725, 181726, exp Feb-20, 181948, exp Mar-20, 181960, exp Feb-20, 182385, 182386, 182387, exp Mar-20
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Quantity
- 2,851,284 bottles
- Recall started
- March 1, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1049-2019
-
Class II Ongoing
Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical…
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
- Lots / codes
- Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Quantity
- 456,732 bottles
- Recall started
- March 1, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1048-2019
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Class II Ongoing
Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 088…
Reason: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots, distribution and details
- Product
- Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
- Lots / codes
- a) LOP17011, Exp Aug-19, Lot LOP17087 Exp Nov-19; b) LOP17012, LOP17013, Exp Aug-19, LOP17042, LOP17043 Exp Oct-19, LOP17044, LOP17045, Exp Nov-19, LOP18024, LOP18025, LOP18026, LOP18027, LOP18028, LOP18029, LOP18030, Exp. Dec-19; c) LOP17005, Exp May-19, LOP17014, Exp Aug-19, LOP17016, LOP17023, Exp Sep-19, LOP17083, Exp Oct-19, LOP17084, LOP17085, LOP17086, Exp Nov-19, LOP18021, LOP18022, LOP18023, LOP18031, LOP18032, LOP18033, LOP18050, LOP18051, Exp Dec-19, LOP18109, LOP18111, Exp Mar-20, LOP18122, LOP18123, LOP18124, LOP18125, LOP18126, LOP18127, LOP18128, LOP18129, LOP18130, LOP18131C, LOP18133, Exp Jun-20
- Distribution
- Nationwide
- Quantity
- 683,641 bottles
- Recall started
- February 28, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1043-2019
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Class II Ongoing
Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 0885…
Reason: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots, distribution and details
- Product
- Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
- Lots / codes
- a) LOP17028C, Exp. Sep-19, LOP17064A, Exp. Nov-19; b) LOP17027, Exp Sep-19, LOP17063, LOP17093, Exp. Nov-19; LOP17094, LOP17095, LOP17097A, LOP17105, LOP17107, Exp. Dec-19; c) LOP17004, Exp Dec-19, LOP17028B, Exp Sep-19, LOP17048, LOP17049 Exp Oct-19, LOP17056, LOP17073, LOP17074, LOP17076 Exp Nov-19, LOP17096, Exp Dec-19, LOP18077A, LOP18078, LOP18079, LOP18080 Exp Feb-20; LOP18081, LOP18084, LOP18095, LOP18096 Exp Mar-20
- Distribution
- Nationwide
- Quantity
- 69712 bottles
- Recall started
- February 28, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1042-2019
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Class II Ongoing
Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ…
Reason: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots, distribution and details
- Product
- Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
- Lots / codes
- a) LOP17026B, LOP17050, LOP1705, LOP17052, LOP17053, Exp. Sep-19; LOP17061, Exp. Oct-19; LOP18035, LOP18036, Exp. Dec-19; b) LOP17026, Exp. Sep-19; c) LOP17006, Exp. May-19, LOP17025, Exp. Sep-19, LOP17068, Exp, Oct-19, LOP18037, LOP18038, LOP18039, Exp. Dec-19, LOP18057, Exp. Jan-20
- Distribution
- Nationwide
- Quantity
- 351,732 bottles
- Recall started
- February 28, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1041-2019
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Class II Ongoing
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-572-90
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: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- 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-1039-2019
-
Class II Ongoing
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-571-90
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: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- 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-1038-2019
-
Class II Ongoing
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-570-30
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 Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-570-30
- Lots / codes
- Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- 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-1037-2019
-
Class II Ongoing
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India — NDC 65862-739-30
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: VFSA17007-A, exp. date Oct-2019
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- 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-1036-2019
-
Class II Ongoing
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-573-90
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 Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-573-90
- Lots / codes
- Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- 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-1035-2019
-
Class II Ongoing
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 7…
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
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 18,780 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0505-2019
-
Class II Ongoing
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382…
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
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 18,852 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0504-2019
-
Class II Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
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
- Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 43,416 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0503-2019
-
Class II Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Ind…
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
- LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [30-count bottle] Lot 4L67C035, exp 10/2019; [90-count bottle] Lot 4L67C035, 4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp 11/2019
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 65,832 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0502-2019
-
Class II Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 7…
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
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [30-count bottle] Lot BO31C016, exp 04/2019; [90-count bottle] Lot BO31C016, exp 04/2019; [1000-count bottle] Lots 4DK3C004, 4DK3C005, exp 04/2019; Lots 4DU3C040, exp 10/2019; Lots 4DU3E049, 4DU3E050, exp 05/2021
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 83,016 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0501-2019
-
Class II Ongoing
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
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 # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 20,604 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-0370-2019
-
Class II Ongoing
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
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 # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot # HVSB17038-A, exp. date 11/2020 Lot # HVSB17039-A, exp. date 11/2020 Lot # HVSB17040-B, exp. date 11/2020 Lot # HVSB18001-A, exp. date 12/2020 Lot # HVSB18002-A, exp. date 12/2020 Lot # HVSB18003-A, exp. date 12/2020 Lot # HVSB18004-A, exp. date 12/2020
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 53,064 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-0369-2019
-
Class II Ongoing
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
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 # HVSA17011-A, exp. date 11/2020 Lot # HVSA17012-A, exp. date 11/2020 Lot # HVSA18001-A, exp. date 12/2020
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 32,160 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-0368-2019
-
Class II Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
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 # HTSB17049-A, exp. date 08/2020 Lot # HTSB17054-A, exp. date 10/2020 Lot # HTSB17055-A, exp. date 10/2020 Lot # HTSB17056-A, exp. date 10/2020 Lot # HTSB17057-A, exp. date 10/2020 Lot # HTSB17058-A, exp. date 10/2020 Lot # HTSB17059-A, exp. date 10/2020 Lot # HTSB17060-A, exp. date 10/2020 Lot # HTSB17062-A, exp. date 10/2020 Lot # HTSB17066-A, exp. date 10/2020 Lot # HTSB17067-A, exp. date 11/2020 Lot # HTSB17068-A, exp. date 11/2020 Lot # HTSB17069-A, exp. date 11/2020 Lot # HTSB18001-A, exp. date 12/2020 Lot # HTSB18002-A, exp. date 12/2020 Lot # HTSB18003-A, exp. date 12/2020 Lot # HTSB18004-A, exp. date 12/2020 Lot # HTSB18005-A, exp. date 12/2020 Lot # HTSB18006-A, exp. date 12/2020 Lot # HTSB18007-A, exp. date 12/2020 Lot # HTSB17063-A, exp. date 10/2020 Lot # HTSB17064-A, exp. date 10/2020 Lot # HTSB17065-A, exp. date 10/2020 Lot # HTSB18029-A, exp. date 03/2021
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Quantity
- 111,239 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-0367-2019
-
Class II Ongoing
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
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 # HTSA17033-A, exp. date 10/2020 Lot # HTSA17034-A, exp. date 10/2020 Lot # HTSA17035-A, exp. date 10/2020 Lot # HTSA17036-A, exp. date 10/2020 Lot # HTSA17040-A, exp. date 10/2020 Lot # HTSA17041-A, exp. date 11/2020 Lot # HTSA17042-A, exp. date 11/2020 Lot # HTSA17043-A, exp. date 11/2020 Lot # HTSA17037-A, exp. date 10/2020 Lot # HTSA17039-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
- 92,616 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-0366-2019
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.