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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.

55 recalls

  • Class II Ongoing

    Ranitidine Tablets, USP 300 mg – a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

    Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

    Amneal Pharmaceuticals, Inc. · Ranitidine

    Lots, distribution and details
    Lots / codes
    AR172033B 11/2019 AR180024A 12/2019 AR180025A 12/2019 AR180118A 12/2019 AR180119A 12/2019 AR180519A 3/2020 AR180615A 3/2020 AR181795A 11/2020 AR181921B 12/2020 AR190705A 4/2021 AR172029A 11/2019 AR172030A 11/2019 AR180021A 12/2019 AR180022A 12/2019 AR180023A 12/2019 AR180123A 12/2019 AR180144A 1/2020 AR180145A 1/2020 AR180146A 1/2020 AR180147A 1/2020 AR180402A 2/2020 AR180465A 2/2020 AR180466A 2/2020 AR180467A 2/2020 AR180468A 2/2020 AR180613A 3/2020 AR181156A 7/2020 AR181157A 7/2020 AR190418B 2/2021 AR171800A 11/2019 AR171801A 11/2019 AR171802A 11/2019 AR171803A 11/2019 AR171804A 11/2019 AR171931A 11/2019 AR171932A 11/2019 AR171933A 11/2019 AR171934A 11/2019 AR171935A 11/2019 AR171936A 11/2019 AR171937A 11/2019 AR172026A 11/2019 AR172027A 11/2019 AR172028A 11/2019 AR172031A 11/2019 AR172032A 11/2019 AR172033A 11/2019 AR172034A 11/2019 AR172035A 11/2019 AR180030A 12/2019 AR180031A 12/2019 AR180032A 12/2019 AR180033A 12/2019 AR180034A 12/2019 AR180113A 12/2019 AR180114A 12/2019 AR180115A 12/2019 AR180117A 12/2019 AR180120A 12/2019 AR180121A 12/2019 AR180122A 12/2019 AR180148A 1/2020 AR180198A 1/2020 AR180199A 1/2020 AR180200A 1/2020 AR180201A 1/2020 AR180202A 1/2020 AR180257A 1/2020 AR180258A 1/2020 AR180335A 2/2020 AR180336A 2/2020 AR180337A 2/2020 AR180338A 2/2020 AR180339A 2/2020 AR180374A 2/2020 AR180375A 2/2020 AR180376B 2/2020 AR180403A 2/2020 AR180404A 2/2020 AR180405A 2/2020 AR180406A 2/2020 AR180424A 2/2020 AR180486A 3/2020 AR180487A 3/2020 AR180488A 3/2020 AR180515A 3/2020 AR180516A 3/2020 AR180517A 3/2020 AR180518A 3/2020 AR180638A 3/2020 AR180640A 4/2020 AR180641A 4/2020 AR181920A 12/2020 AR181921A 12/2020 AR190414B 2/2021 AR190415A 2/2021 AR190416A 2/2021 AR190417A 2/2021 AR190418A 2/2021 AR190543A 3/2021 AR190544A 3/2021 AR190545A 3/2021
    Distribution
    Product was distributed throughout the United States.
    Quantity
    N/A
    Recall started
    November 22, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0613-2020
  • Class II Ongoing

    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (…

    Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

    Amneal Pharmaceuticals, Inc. · Ranitidine

    Lots, distribution and details
    Product
    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
    Lots / codes
    AR171764A 11/2019 AR171875A 11/2019 AR171876A 11/2019 AR171981A 11/2019 AR180020C 1/2020 AR180206A 1/2020 AR180207A 1/2020 AR180208A 1/2020 AR180438A 2/2020 AR180439A 2/2020 AR180481A 3/2020 AR180482A 3/2020 AR180483A 3/2020 AR181690A 10/2020 AR181691A 10/2020 AR181806A 11/2020 AR190058A 12/2020 AR190059A 12/2020 AR190183A 1/2021 AR190184A 1/2021 AR171984A 12/2019 AR180020B 1/2020 AR180675A 4/2020 AR180868B 5/2020 AR181807A 11/2020 AR190366B 2/2021 AR171986A 12/2019 AR171987A 12/2019 AR180255A 1/2020 AR180441A 2/2020 AR180442A 2/2020 AR180559A 3/2020 AR180560A 3/2020 AR180594A 3/2020 AR180595A 3/2020 AR180829A 4/2020 AR180831A 5/2020 AR180832A 5/2020 AR180868A 5/2020 AR181807C 11/2020 AR190085A 12/2020 AR190086A 12/2020 AR190087A 12/2020 AR190124A 1/2021 AR190542B 3/2021 AR190609A 3/2021 AR190610A 3/2021 AR171875B 11/2019 AR180483B 3/2020 AR181807B 11/2020 AR190008B 12/2020 AR171763A 11/2019 AR171764B 11/2019 AR171874A 11/2019 AR171875C 11/2019 AR171877B 11/2019 AR171878B 11/2019 AR171982A 11/2019 AR171983A 12/2019 AR171985A 12/2019 AR180016A 12/2019 AR180017A 12/2019 AR180018A 12/2019 AR180019A 12/2019 AR180020A 1/2020 AR180208B 1/2020 AR180256A 1/2020 AR180291A 1/2020 AR180292A 1/2020 AR180293A 1/2020 AR180294A 2/2020 AR180295A 2/2020 AR180364A 2/2020 AR180365A 2/2020 AR180366A 2/2020 AR180367A 2/2020 AR180368A 2/2020 AR180440B 2/2020 AR180484A 3/2020 AR180485A 3/2020 AR180556A 3/2020 AR180557A 3/2020 AR180558A 3/2020 AR180596A 3/2020 AR180597A 3/2020 AR180598A 3/2020 AR180599A 3/2020 AR180675B 4/2020 AR180676A 4/2020 AR180677A 4/2020 AR180678A 4/2020 AR180679A 4/2020 AR180801A 4/2020 AR180802A 4/2020 AR180803A 4/2020 AR180869A 5/2020 AR180870A 5/2020 AR180871A 5/2020 AR180872A 5/2020 AR180994A 5/2020 AR180995A 5/2020 AR180996A 5/2020 AR180997A 6/2020 AR180998A 6/2020 AR181158A 7/2020 AR181159A 7/2020 AR181160A 7/2020 AR181161A 7/2020 AR181692A 10/2020 AR181693A 10/2020 AR181694A 10/2020 AR181709A 10/2020 AR181710A 11/2020 AR181711A 11/2020 AR181808A 11/2020 AR181809A 11/2020 AR190004A 12/2020 AR190005A 12/2020 AR190006A 12/2020 AR190007A 12/2020 AR190008A 12/2020 AR190088A 12/2020 AR190089A 12/2020 AR190090A 12/2020 AR190121A 12/2020 AR190122A 12/2020 AR190123A 12/2020 AR190125B 1/2021 AR190181A 1/2021 AR190182A 1/2021 AR190364A 2/2021 AR190365A 2/2021 AR190366A 2/2021 AR190509A 3/2021 AR190510A 3/2021
    Distribution
    Product was distributed throughout the United States.
    Quantity
    N/A
    Recall started
    November 22, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0612-2020
  • Class II Ongoing

    Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

    Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

    AuroMedics Pharma LLC

    Lots, distribution and details
    Lots / codes
    RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021
    Distribution
    nationwide
    Quantity
    26,736 bottles
    Recall started
    November 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0530-2020
  • Class II Ongoing

    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

    Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

    AuroMedics Pharma LLC

    Lots, distribution and details
    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
    Lots / codes
    UI1519001-A UI1519002-A UI1519003-A UI1519004-A
    Distribution
    nationwide
    Quantity
    19320 bottles
    Recall started
    November 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0529-2020
  • Class II Ongoing

    Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

    Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

    AuroMedics Pharma LLC

    Lots, distribution and details
    Product
    Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
    Lots / codes
    RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021
    Distribution
    nationwide
    Quantity
    134,160 bottles
    Recall started
    November 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0528-2020
  • Class II Ongoing

    Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

    Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

    AuroMedics Pharma LLC

    Lots, distribution and details
    Product
    Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
    Lots / codes
    RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
    Distribution
    nationwide
    Quantity
    45,456 bottles
    Recall started
    November 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0527-2020
  • Class II Ongoing

    DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

    Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

    AuroMedics Pharma LLC

    Lots, distribution and details
    Product
    DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
    Lots / codes
    Lot # NBSB19001DA3; Exp FEB 2021
    Distribution
    nationwide
    Quantity
    69,696 bottles
    Recall started
    November 6, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0526-2020
  • 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

    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.

    Torrent Pharma Inc. · Losartan Potassium

    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.

    Torrent Pharma Inc. · Losartan Potassium

    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.

    Torrent Pharma Inc. · Losartan Potassium

    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.

    Aurobindo Pharma USA Inc. · Valsartan

    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.

    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

    Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.

    Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Aurobindo Pharma USA Inc. · Amlodipine and Valsartan

    Lots, distribution and details
    Lots / codes
    Lot # VKSA18005-A, exp. date 03/2020 Lot # VKSA18001-A, exp. date 01/2020
    Distribution
    Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
    Quantity
    55,788 bottles
    Recall started
    December 31, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0364-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.

    Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Aurobindo Pharma USA Inc. · Amlodipine and Valsartan

    Lots, distribution and details
    Lots / codes
    Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019
    Distribution
    Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
    Quantity
    27,688 bottles
    Recall started
    December 31, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0363-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.

    Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Aurobindo Pharma USA Inc. · Amlodipine and Valsartan

    Lots, distribution and details
    Lots / codes
    Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. 01/2020 Lot # VFSA18007-A, exp. 03/2020 Lot # VFSA18008-A, exp. 03/2020 Lot # VKSA17008-A, exp. 05/2019 Lot # VFSA17009-A, exp. 10/2019 Lot # VKSA17014-A, exp. 10/2019 Lot # VKSA17015-A, exp. 10/2019 Lot # VKSA17016-A, exp. 10/2019 Lot # VKSA17017-A, exp. 10/2019 Lot # VKSA18002-A, exp. 01/2020 Lot # VKSA18004-A, exp. 01/2020
    Distribution
    Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
    Quantity
    60,417 bottles
    Recall started
    December 31, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0362-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

    Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Aurobindo Pharma USA Inc. · Amlodipine and Valsartan

    Lots, distribution and details
    Product
    Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
    Lots / codes
    Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
    Distribution
    Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
    Quantity
    18,408 bottles
    Recall started
    December 31, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0361-2019
  • Class II Ongoing

    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD.…

    Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

    Teva Pharmaceuticals USA · Amlodipine

    Lots, distribution and details
    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Lots / codes
    All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    31,079 bottles
    Recall started
    November 27, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0310-2019
  • Class II Ongoing

    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD.…

    Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

    Teva Pharmaceuticals USA · Amlodipine

    Lots, distribution and details
    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Lots / codes
    NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    37,957 bottles
    Recall started
    November 27, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0309-2019
  • Class II Ongoing

    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD…

    Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

    Teva Pharmaceuticals USA · Amlodipine

    Lots, distribution and details
    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Lots / codes
    NDC 0093-7810-56 & NDC 0093-7810-98 Lot # 20X006
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    19,458 bottles
    Recall started
    November 27, 2018 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0308-2019

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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