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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.

38 recalls

  • 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 Ongoing

    LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00

    Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Teva Pharmaceuticals USA · Losartan Potassium

    Lots, distribution and details
    Lots / codes
    1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020
    Distribution
    Bulk product was distributed to one re-packager in California.
    Quantity
    N/A
    Recall started
    March 25, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1102-2020
  • Class II Ongoing

    LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00

    Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Teva Pharmaceuticals USA · Losartan Potassium

    Lots, distribution and details
    Product
    LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
    Lots / codes
    Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020
    Distribution
    Bulk product was distributed to one re-packager in California.
    Quantity
    N/A
    Recall started
    March 25, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1101-2020
  • Class II Ongoing

    LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00

    Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Teva Pharmaceuticals USA · Losartan Potassium

    Lots, distribution and details
    Lots / codes
    Lots 1207344A, exp. date 06/2020; 1207343A, 1207342A, exp. date 07/2020
    Distribution
    Bulk product was distributed to one re-packager in California.
    Quantity
    N/A
    Recall started
    March 25, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1100-2020
  • 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 Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10

    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. · Losartan Potassium

    Lots, distribution and details
    Product
    Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
    Lots / codes
    Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    39,432 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-0122-2020
  • Class II Ongoing

    Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10

    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. · Losartan Potassium

    Lots, distribution and details
    Product
    Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
    Lots / codes
    Lot 4DU2E009
    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-0121-2020
  • Class II Ongoing

    LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

    Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Teva Pharmaceuticals USA

    Lots, distribution and details
    Product
    LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
    Lots / codes
    Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
    Distribution
    Nationwide by 4 major distributors.
    Quantity
    2,943,000 tablets
    Recall started
    June 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1456-2019
  • Class II Ongoing

    LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00

    Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Teva Pharmaceuticals USA

    Lots, distribution and details
    Product
    LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
    Lots / codes
    Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020
    Distribution
    Nationwide by 4 major distributors.
    Quantity
    2,924,000 tablets
    Recall started
    June 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1455-2019
  • 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 Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

    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

    Lots, distribution and details
    Product
    Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Lots / codes
    Count, lots, expiry: [90-count bottle] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    65,184 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-1266-2019
  • Class II Ongoing

    Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

    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

    Lots, distribution and details
    Product
    Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Lots / codes
    Count, lots, expiry: [90-count bottle] Lots 4DU2D005, 4DU2D006, exp 12/31/2019; Lots 4DU2D026, 4DU2D027, 4DU2D029, exp 3/31/2020; Lot 4DU2E007, exp 12/31/2020; [1000-count bottle] Lot 4DU2D017, exp 2/29/2020, Lots 4DU2D025, 4DU2D028, exp 3/31/2020; Lots 4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047, 4DU2D048, exp 8/31/2020; Lot BDK2E001, exp 12/31/2020; Lots 4DU2E042, 4DU2E044, exp 2/28/2021; Lots BDK2E012, BDK2E013, exp 8/31/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    164,424 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-1265-2019
  • Class II Ongoing

    Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

    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

    Lots, distribution and details
    Product
    Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
    Lots / codes
    Count, lots, expiry: [90-count bottle] Lot BDK1C003, exp 07/31/2019; [1000-count bottle] Lot BDK1C002, exp 07/31/2019; Lots 4DU1D004, 4DU1D005, 4DU1D006, exp 12/31/2019
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    28,464 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-1264-2019
  • Class II Ongoing

    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged…

    Reason: CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

    Legacy Pharmaceutical Packaging LLC · Losartan Potassium

    Lots, distribution and details
    Product
    Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
    Lots / codes
    Lot 181598; 02/2021
    Distribution
    TN, AZ
    Quantity
    60,012 bottles
    Recall started
    April 24, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1263-2019
  • Class II Ongoing

    Losartan Potassium Tablets USP 25 mg 50 tablets (5×10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

    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 0.96 parts per million.

    AVKARE Inc.

    Lots, distribution and details
    Lots / codes
    Lot: 19554 Exp. 4/30/2019
    Distribution
    Nationwide
    Quantity
    846 cartons (42,300 tablets)
    Recall started
    April 24, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1250-2019
  • Class II Ongoing

    Losartan Potassium Tablets USP 50 mg 50 tablets (5×10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

    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 0.96 parts per million.

    AVKARE Inc.

    Lots, distribution and details
    Lots / codes
    Lot: 20121 Exp. 6/30/2019
    Distribution
    Nationwide
    Quantity
    1438 cartons (71,900 tablets)
    Recall started
    April 24, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1249-2019
  • 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 TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: To…

    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

    Lots, distribution and details
    Product
    LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), 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: [90-count bottle] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    121,668 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-1116-2019
  • Class II Ongoing

    LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 7…

    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

    Lots, distribution and details
    Product
    LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), 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 4DU2D077, exp 10/31/2020; [90-count bottle] Lot 4DU2D087, exp 10/31/2020; Lots 4DU2E023, 4DU2E024, 4DU2E026, 4DU2E027, 4DU2E028, 4DU2E029, 4DU2E020, exp 1/31/2021; Lots 4O50E007, 4O50E008, exp 8/31/2021; [1000 count bottle] Lots 4DU2D067, 4DU2D069, 4DU2D063, 4DU2D064, 4DU2D065, 4DU2D066, exp 9/30/2020; Lots 4DU2D084, 4DU2D085, 4DU2D083, 4DU2D082, 4DU2D072, 4DU2D077, 4DU2D078, 4DU2D079, 4DU2D081, 4DU2D080, 4DU2D070, 4DU2D073, 4DU2D074, 4DU2D075, 4DU2D086, 4DU2D088, 4DU2D089, exp 10/31/2020; Lots 4DU2E019, 4DU2E021, 4DU2E022, 4DU2E025, exp 1/31/2021; Lots 4DU2E032, 4DU2E033, 4DU2E034, 4DU2E035, 4DU2E036, 4DU2E037, 4DU2E038, 4DU2E039, 4DU2E041, exp 2/28/2021; Lots 4DU2E103, 4DU2E101, 4DU2E102, exp 6/30/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    476,340 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-1115-2019
  • Class II Ongoing

    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Tor…

    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

    Lots, distribution and details
    Product
    LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), 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: [90-count bottle ] Lots 4DU1E005, 4DU1E006, 4DU1E008, exp 1/31/2021; Lots 4DU1E007, exp 1/31/2021
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    133,992 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-1114-2019

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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