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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.

19 recalls

  • Class I Ongoing

    Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings…

    Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

    JB Chemicals and Pharmaceuticals Ltd · Cetirizine Hydrochloride

    Lots, distribution and details
    Product
    Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
    Lots / codes
    Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
    Distribution
    Nationwide in the USA
    Quantity
    34,020 100-count bottles.
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0732-2026
  • Class II Ongoing

    Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05

    Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
    Lots / codes
    7701034A 7701057A 7701058A 7701059A 7701060A 7701061A 7701071A 7701072A 7701073A 7701074A 7701105A 7701106A 7701107A 7701108A 7701109A 7701113A 7701114A 7701115A 7701116A 7701121A 7701122A 7701123A 7701124A 7701125A 7701126A 7701151A 7701152A 7701165A 7701154A 7701155A 7701163A 7701176A 7701190A 7701221A 7701222A 7701223A 7701224A 7701225A 7701235A 7701253A 7701254A 7701255A 7701256A 7701257A 7701258A 7701259A 7701266A 7701267A 7701268A 7701273A 7701275A 7701276A 7701277A 7701294A 7701295A 7701296A 7701297A 7701300A 7701301A 7701302A 7701303A 7701304A 7701306A 7701307A 7701308A 7701309A 7701310A 7701311A 7701312A 7701313A 7701314A 7701315A 7701316A 7701328A 7701329A 7701330A 7701331A 7701332A 7701333A 7701344A 7701153A 7701175A 7701234A 7701274A 7701305A 7701345A 7701352A 7701353A 7701354A 7701355A 7701356A 7701382A 7701383A 7701384A 7701385A 7701402A 7701403A 7701404A 7701405A 7701419A 7701420A 7701422A 7701423A 7701424A 7701425A 7701426A 7701427A 7701430A 7701432A 7701433A 7701448A 7701449A 7701450A 7701451A 7701454A 7701455A 7701471B 7701557A 7701558A 7701559A 7701583A 7701584A 7701585A 7701586A 7701587A 7701588A 7701614A 7701615A 7701616A 7701621A 7701637A 7701638A 7701639A 7701652A 7701653A 7701654A 7701655A 7701656A 7701657A 7701658A 7701664A 7701665A 7701666A 7701667A 7701668A 7701669A 7701670A 7701680A 7701613A 7701699A 7701700A 7701701A 7701714A 7701715A 7701716A 7701717A 7701718A 7701719A 7701720A 7701721A 7701781A 7701782A 7701783A 7701784A 7701796A 7701926A 7701927A 7701937A 7701938A 7701939A 7701940A 7701941A 7702004A 7702005A 7702006A 7702007A 7702008A 7702009A 7702010A 7702011A 7702013A 7702014A 7702068A 7702222A 7702223A 7702224A 7702230A 7702231A 7702232A 7702233A 7702242B 7702243A 7702244A 7702245A 7702246A 7702247A 7702248A 7702249A 7702250A 7702251A 7702252A 7702291A 7702292A 7702293A 7702302A 7702303A 7702304A 7702305A 7702306A 7702307A 7702308A 7702309A 7702331A 7702332A 7702333A 7702334A 7702339A 7702340A 7702346A 7702353A 7702354A 7702355A 7702356A 7702376A 7702377A 7702378A 7702379A 7702390A 7702310A 7702411A 7702412A 7702490A 7702493A 7702494A 7702498A 7702499A 7702500A 7702501A 7702502A 7702503A 7702516A 7702517A 7702518A 7702519A 7702549A 7702550A 7702551A 7702552A 7702601A 7702602A 7702603A 7702604A 7702605A 7702606A 7702607A 7702608A 7702621A 7702622A 7702623A 7702655A 7702656A 7702657A 7702658A 7702741A 7702742A 7702743A 7702765A 7702766A 7702777A 7702778A 7702779A 7702780A 7702781A 7702782A 7702783A 7702784A 7702794A 7702795A 7702796A 7702797A 7702811A 7702812A 7702813A 7702814A 7702815A 7702816A 7702817A 7702818A 7702819A 7702820A 7702821A 7702822A 7702848A 7702849A 7702850A 7702856A 7702857A 7702861A 7702896A 7702897A 7702898A 7702899A 7702910A 7702911A 7702912A 7702913A 7702914A 7702915A 7702916A 7702924A 7702925A 7702926A 7702927A 7703060A 7703061A 7703062A 7703063A 7703064A 7703065A 7703066A 7703067A 7703068A 7703144A 7703145A 7703146A 7703147A 7703174A 7703175A 7703176A 7703177A 7703178A 7703179A 7703180A 7703181A 7703182A 7703183A 7703191A 7703192A 7703193A 7703194A 7703195A 7703236A 7703237A 7703238A 7703239A 7703240A 7703248A 7703249A 7703250A 7703251A 7703252A 7703253A 7703254A 7703255A 7703283A 7703284A 7703290A 7703291A 7703292A 7703293A 7703294A 7703295A 7703296A 7703318A 7703330A 7703331A 7703332A 7703333A 7703334A 7703347A 7703348A 7703349A 7703350A 7703351A 7703394A 7703395A 7703409A 7703491A 7703492A 7703493A 7703494A 7703495A 7703496A 7703497A 7703498A 7703499A 7703500A 7703501A 7703502A 7703503A 7703504A 7703635A 7703636A 7703637A 7703638A 7703775A 7703776A 7703777A 7703778A 7703779A 7703780A 7703781A 7703782A 7703783A 7703925A 7703926A 7703934A 7703935A 7703936A 7703937A 7703938A 7703939A 7703970A 7703971A 7703972A 7704003A 7704004A 7704098A 7704099A 7704100A 7704101A 7704102A 7704103A 7704104A 7704181A 7704182A 7704183A 7704184A 7704185A 7704186A 7704187A 7704188A 7704189A 7704190A 7704191A 7704192A 7704193A 7704297A 7704298A 7704299A 7704300A 7704301A 7704302A 7704327A 7704328A 7704329A 7704330A 7704331A 7704332A 7704333A 7704334A 7704408A 7704409A 7704410A 7704411A 7704412A 7704413A 7704419A 7704420A 7704421A 7704422A 7704423A 7704424A 7704425A 7704496A 7704497A 7704502A 7704503A 7704504A 7704505A 7704506A 7704507A 7704559A 7704560A 7704561A 7704562A 7704574A 7704575A 7704606A 7704607A 7704608A 7704649A 7704650A 7704651A 7704652A 7704653A 7704654A 7704655A 7704656A 7704657A 7704658A 7704659A 7704673A 7704674A 7704675A 7704676A 7704677A 7704678A 7704679A 7704735A 7704736A 7704737A 7704738A 7704739A 7704810A 7704811A 7704812A 7704834A 7704835A 7704836A 7704837A 7704856A 7704857A 7704948A 7704949A 7704950A 7704951A 7704971A 7704972A 7704973A 7704974A 7704975A 7704976A 7704977A 7704980A 7704981A 7704982A 7704983A 7704984A 7704985A 7705014A 7705049A 7705125A 7705126A 7705127A 7705128A 7705129A 7705130A 7705131A 7705132A 7705133A 7705134A 7705135A 7705136A 7705137A 7705138A 7705150A 7705151A 7705152A 7705153A 7705382A 7705383A 7705386A 7705388A 7705391A 7705566A 7705568A 7705569A 7705589A 7705591A 7705595A 7705596A 7705597A 7705598A 7705599A 7705600A 7705601A 7705614A 7705615A 7705618A 7705619A 7705620A 7705621A 7705622A 7705623A 7705624A 7705387A 7705389A 7705390A 7705592A 7705593A 7705594A 7705602A 7705616A 7705617A 19190289 19190342 19190372 19190385 19191898 19192447 19192461 19192468 19192481 7702624A 7702625A 7702738A 7702739A 7702740A 7704858A 7704859A 7704860A 7704861A 7704892A 7704893A 7704894A 7704895A 7704896A 7704912A 7704926A 7704927A 7704928A 7704929A 7704930A 7704931A 7704932A
    Distribution
    Natiowide
    Quantity
    1,712,632 bottles
    Recall started
    December 17, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0644-2020
  • Class II Ongoing

    Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

    Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
    Lots / codes
    7701069A 7701070A 7701084A 7701085A 7701087A 7701094A 7701095A 7701140A 7701141A 7701142A 7701157A 7701162A 7701182A 7701217A 7701218A 7701219A 7701236A 7701237A 7701220A 7701456A 7701470A 7701520A 7701671A 7701696A 7701697A 7701698A 7701797A 7701928A 7701929A 7701942A 7701943A 7702065A 7702066A 7702067A 7702095A 7702096A 7702097A 7702098A 7702188A 7702189A 7702190A 7702196A 7702197A 7702198A 7702199A 7702348A 7702338A 7702347A 7702349A 7702350A 7702391A 7702392A 7702546A 7702547A 7702548A 7702616A 7702617A 7702618A 7702619A 7702620A 7702763A 7702764A 7702851A 7702852A 7702853A 7702854A 7702855A 7702868A 7702869A 7702870A 7702871A 7702920A 7703054A 7703055A 7703056A 7703057A 7703058A 7703206A 7703208A 7703454A 7703455A 7703456A 7703486A 7703487A 7703488A 7703489A 7703490A 7703945A 7703946A 7703947A 7704111A 7704112A 7704113A 7704234A 7704235A 7704236A 7704237A 7704285A 7704286A 7704287A 7704288A 7704370A 7704371A 7704428A 7704429A 7704430A 7704431A 7704814A 7704838A 7704839A 7704840A 7704935A 7704936A 7704992A 7704996A 7704997A 7704998A 7704999A 7705037A 7705298A 7705299A 7705300A 7705301A 7705302A 7705303A 7705546A 7705584A 7705544A 7705545A 7705572A 7705585A 19190456 19190472 19190490 19191934 19191942 19191959 19192504
    Distribution
    Natiowide
    Quantity
    500,960 bottles
    Recall started
    December 17, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0643-2020
  • Class II Ongoing

    Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01

    Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
    Lots / codes
    7701030A 7701031A 7701062A 7701063A 7701110A 7701111A 7701112A 7701185A 7701186A 7701187A 7701188A 7701189A 7701269A 7701270A 7701278A 7701279A 7701386A 7701400A 7701401A 7701406A 7701421A 7701434A 7701435A 7701436A 7701452A 7701453A 7701521A 7701522B 7701553A 7701554A 7701555A 7701556A 7701582A 7701817A 7701828A 7701829A 7702001A 7702002A 7702003A 7702012A 7702026A 7702027A 7702064A 7702140A 7702253A 7702254A 7702285A 7702286A 7702287A 7702288A 7702294A 7702413A 7702462A 7702491A 7702492A 7702504A 7702505A 7702515A 7702698A 7702699A 7702700A 7702714A 7702719A 7702720A 7702747A 7702748A 7702749A 7702750A 7702751A 7702872A 7702873A 7702874A 7702917A 7702918A 7702919A 7702921A 7702922A 7702923A 7702945A 7703205A 7703410A 7703411A 7703412A 7703413A 7703414A 7703415A 7703451A 7703452A 7703453A 7703578A 7703579A 7703580A 7703581A 7703591A 7703592A 7703593A 7704372A 7704373A 7704374A 7704426A 7704427A 7704432A 7704463A 7704464A 7704465A 7704466A 7704508A 7704509A 7704510A 7704511A 7704512A 7704513A 7704563A 7704564A 7704746A 7704747A 7704748A 7704813A 7704841A 7704989A 7704990A 7705106A 7705320A 7705321A 7705322A 7705323A 7705324A 7705325A 7705326A 7705694A 7705703A 7705704A 7705702A 19190456 19190472 19190490 7701809A 7704862A 7704863A 7704864A 7704865A 7704866A 7704933A 7704934A
    Distribution
    Natiowide
    Quantity
    1,309,536 bottles
    Recall started
    December 17, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0642-2020
  • Class II Ongoing

    Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

    Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
    Lots / codes
    7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
    Distribution
    Natiowide
    Quantity
    98,988 bottles
    Recall started
    December 17, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0641-2020
  • Class II Ongoing

    Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

    Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
    Lots / codes
    7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372
    Distribution
    Natiowide
    Quantity
    217,956 bottles
    Recall started
    December 17, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0640-2020
  • Class II Ongoing

    Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

    Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
    Lots / codes
    7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A
    Distribution
    Natiowide
    Quantity
    208,668 bottles
    Recall started
    December 17, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0639-2020
  • Class II Ongoing

    RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

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

    Granules India Limited · Ranitidine

    Lots, distribution and details
    Product
    RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
    Lots / codes
    7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
    Distribution
    OR, NY, NJ
    Quantity
    23,090,000 tablets
    Recall started
    December 13, 2019 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0632-2020
  • Class II Ongoing

    Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

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

    Amneal Pharmaceuticals, Inc. · Ranitidine

    Lots, distribution and details
    Lots / codes
    HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
    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-0616-2020
  • Class II Ongoing

    Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

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

    Amneal Pharmaceuticals, Inc. · Ranitidine

    Lots, distribution and details
    Lots / codes
    HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
    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-0615-2020
  • Class II Ongoing

    Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

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

    Amneal Pharmaceuticals, Inc.

    Lots, distribution and details
    Lots / codes
    06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
    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-0614-2020
  • 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 III Ongoing

    Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

    Reason: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

    AuroMedics Pharma LLC · Ranitidine

    Lots, distribution and details
    Product
    Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
    Lots / codes
    Lot #: NBSB19001DA3, Exp. date 02/2021
    Distribution
    Nationwide within the United States
    Quantity
    69696 bottles
    Recall started
    September 23, 2019 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0166-2020

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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