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Drug Recalls

Last updated

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.

0 Class I (most serious) drug recalls reported in the last 30 days.

52 recalls

  • Class II Ongoing

    Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for:…

    Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

    Unichem Pharmaceuticals USA Inc. · Bisoprolol Fumarate and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
    Lots / codes
    Lot # GBHL24005A, Exp Date: 09/2026
    Distribution
    US Nationwide and PR.
    Quantity
    N/A
    Recall started
    January 21, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0301-2026
  • Class III Ongoing

    Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manu…

    Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

    Glenmark Pharmaceuticals Inc., USA · Bisoprolol Fumarate and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
    Lots / codes
    Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
    Distribution
    Nationwide in the USA
    Quantity
    11,136 bottles
    Recall started
    November 21, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0199-2026
  • Class II Ongoing

    Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

    Reason: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

    Lupin Pharmaceuticals Inc. · Lisinopril and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
    Lots / codes
    Lot #: QA01081, Exp. Date April 2027
    Distribution
    Product was distributed nationwide within the United States.
    Quantity
    58,968 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0532-2025
  • Class II Ongoing

    Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Hi…

    Reason: Presence of foreign substance: plastic-like substance.

    MACLEODS PHARMA USA, INC · Losartan Potassium and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
    Lots / codes
    Lot #: BLK2304A, Exp. 07/31/2025
    Distribution
    USA Nationwide
    Quantity
    1,048 bottles
    Recall started
    May 7, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0498-2024
  • Class II Terminated

    Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Triamterene and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
    Lots / codes
    Batch 21000279A, 21000280A
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0199-2024
  • Class II Terminated

    Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, Ind…

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Lisinopril and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
    Lots / codes
    Batch Q101699, Q101981
    Distribution
    Nationwide USA
    Quantity
    2 units
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0188-2024
  • Class III Terminated

    Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Phar…

    Reason: Failed Impurities/Degradation Specifications

    Glenmark Pharmaceuticals Inc., USA · Bisoprolol Fumarate and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
    Lots / codes
    Lot# 17212352, Exp 11/31/2023
    Distribution
    Nationwide in the USA
    Quantity
    480 100-count bottles
    Recall started
    October 20, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0085-2024
  • Class II Ongoing

    Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0846-2023
  • Class II Ongoing

    Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Product
    Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0800-2023
  • Class II Ongoing

    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

    Reason: 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.

    Torrent Pharma Inc.

    Lots, distribution and details
    Product
    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
    Lots / codes
    Lot 4P04D007
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    8,688 bottles
    Recall started
    September 19, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0124-2020
  • Class II Ongoing

    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

    Reason: 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.

    Torrent Pharma Inc.

    Lots, distribution and details
    Product
    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
    Lots / codes
    Lot BEF7D051
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    17,088 bottles
    Recall started
    September 19, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0123-2020
  • Class II Ongoing

    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharm…

    Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

    Torrent Pharma Inc. · Losartan Potassium and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Lots / codes
    Count, lots, expiry: [30-count bottle] Lot BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lots BP04D012, BP04D013, exp 12/31/2019; Lots BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020; Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020; Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    239,016 bottles
    Recall started
    April 18, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1269-2019
  • Class II Ongoing

    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721…

    Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

    Torrent Pharma Inc. · Losartan Potassium and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Lots / codes
    Count, lots, expiry: [90-count bottle] Lot BX35D024, exp 1/31/2020; BEF8D060, BEF8D061, BEF8D062, BEF8D063, BEF8D064, exp 11/30/2020; [1000-count bottle] Lot BEF8D059, exp 11/30/2020; Lots BEF8E004, BEF8E005, exp 1/31/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    54,084 bottles
    Recall started
    April 18, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1268-2019
  • Class II Ongoing

    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pha…

    Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

    Torrent Pharma Inc. · Losartan Potassium and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Lots / codes
    Count, lots, expiry: [30-count bottle] Lot BP02C051, exp 10/31/2019; Lot BP02D005, exp 12/31/2019; Lot BEF7D047, exp 11/30/2020; [90-count bottle] Lot BP02C050, exp 10/31/2019; Lots BP02D006, BP02D007, exp 12/31/2019; Lot BP02D012, exp 1/31/2020; Lot BEF7D003, exp 3/31/2020; Lots BEF7D026, BEF7D027, BEF7D028, exp 8/31/2020; Lots BEF7D045, BEF7D046, exp 11/30/2020; Lot BEF7E005, exp 1/31/2021; [1000-count bottle] Lots BP02C051, BP02C052, exp 10/31/2019; Lot BEF7D005, exp 3/31/2020; Lots BEF7D029, BEF7D030, exp 8/31/2020; Lot BEF7D048, exp 11/30/2020; Lots BEF7E001, BEF7E002, BEF7E003, BEF7E004, exp 12/31/2020
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    331,764 bottles
    Recall started
    April 18, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1267-2019
  • Class II Ongoing

    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmac…

    Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

    Torrent Pharma Inc.

    Lots, distribution and details
    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
    Lots / codes
    Count, lots, expiry: [30-count bottle] Lot BEF6D038, exp 4/30/2020; [90-count bottle] Lots BEF6D030, BEF6D031, exp 4/30/2020; Lots BEF6D047, BEF6D048, BEF6D049, BEF6D050, BEF6D051, exp 7/31/2020; Lots BEF6D082, BEF6D083, BEF6D084, BEF6D085, BEF6D086, BEF6D087, exp 10/31/2020; Lots 4P04E003, 4P04E004, 4P04E005, 4P04E006, exp 1/31/2021; [1000-count bottle] 4P04E007, 4P04E008, 4P04E009, exp 1/31/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    173,760 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-1119-2019
  • Class II Ongoing

    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dis…

    Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

    Torrent Pharma Inc.

    Lots, distribution and details
    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
    Lots / codes
    Count, lots, expiry: [30-count bottle] Lot BEF8D058,exp 11/30/2020 [90-count bottle] Lots BEF8D009, BEF8D010, BEF8D011, BEF8D012, BEF8D013, BEF8D007, BEF8D008, exp 3/31/2020; Lots BEF8D023, BEF8D024, BEF8D025, BEF8D020, BEF8D021, BEF8D022, exp 4/30/2020; Lots BEF8D054, BEF8D055, BEF8D056, exp 10/31/2020; Lots BEF8D057, exp 11/30/2020
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    172,296 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-1118-2019
  • Class II Ongoing

    Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharma…

    Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

    Torrent Pharma Inc.

    Lots, distribution and details
    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ
    Lots / codes
    Count, lots, expiry: [30-count bottle] Lot BEF7D017,exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2020; Lot BEF7D018, exp 6/30/2020; Lot BEF7D009, exp 4/30/2020; Lots 4P02E002, 4P02E003, 4P02E004, exp 1/31/2021; [1000-count bottle] Lots BEF7D008, BEF7D012, BEF7D013, exp 4/30/2020; Lot BEF7D022, exp 8/31/2020; Lot BEF7D049, exp 11/30/2020; Lots 4P02E005, 4P02E006, exp 1/31/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    N/A
    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-1117-2019
  • 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.

    Torrent Pharma Inc. · Losartan Potassium and Hydrochlorothiazide

    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.

    Torrent Pharma Inc. · Losartan Potassium and Hydrochlorothiazide

    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

    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.

    Aurobindo Pharma USA Inc. · Valsartan and Hydrochlorothiazide

    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.

    Aurobindo Pharma USA Inc. · Valsartan and Hydrochlorothiazide

    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.

    Aurobindo Pharma USA Inc. · Valsartan and Hydrochlorothiazide

    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.

    Aurobindo Pharma USA Inc. · Valsartan and Hydrochlorothiazide

    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
  • 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.

    Aurobindo Pharma USA Inc. · Valsartan and Hydrochlorothiazide

    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

    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.

    Mylan Laboratories Limited, (Nashik FDF) · Valsartan and Hydrochlorothiazide

    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

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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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