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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.

49 recalls

  • Class II Ongoing

    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

    Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Lots / codes
    Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25
    Distribution
    Nationwide
    Quantity
    244,460 bottles
    Recall started
    December 30, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0190-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

    Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
    Distribution
    Nationwide
    Quantity
    73,680 bottles
    Recall started
    December 30, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0189-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

    Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Lots / codes
    a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
    Distribution
    Nationwide
    Quantity
    42,527 bottles
    Recall started
    December 30, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0188-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged b…

    Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

    RemedyRepack Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
    Lots / codes
    a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
    Distribution
    Nationwide in the US
    Quantity
    a) 1,564 cards, b) 799 bottles
    Recall started
    December 2, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0165-2025
  • Class II Terminated

    DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

    Reason: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

    PD-Rx Pharmaceuticals, Inc. · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot # I24E77, A24E49, Exp Date: 04/30/25; J23C50, J23C97, L23B39, L23E98, Exp Date: 01/31/2025
    Distribution
    Distributed within US: FL, MS, WI
    Quantity
    70, 90-count bottles
    Recall started
    December 4, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0163-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berke…

    Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
    Lots / codes
    Lot # 230077C, exp. date 11/2025
    Distribution
    Nationwide in the US
    Quantity
    76,968 bottles
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0162-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkel…

    Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
    Lots / codes
    Lot # 222205C, exp. date 11/2025
    Distribution
    Nationwide in the US
    Quantity
    163,883 bottles
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0161-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
    Distribution
    Nationwide in the USA
    Quantity
    1,815 bottles
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0158-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot DT6023061B Exp 01/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    20,734 30-count bottles
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0157-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot DT3023030A Exp 2/28/2025
    Distribution
    Nationwide in the USA
    Quantity
    13,678 bottles
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0156-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot DT3023029A Exp 02/28/2025
    Distribution
    Nationwide in the USA
    Quantity
    21,262 bottles
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0155-2025
  • Class II Ongoing

    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Lots / codes
    a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-25
    Distribution
    Nationwide.
    Quantity
    233,003 bottles
    Recall started
    November 19, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0107-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Bru…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
    Lots / codes
    a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25
    Distribution
    Nationwide.
    Quantity
    122,925 bottles
    Recall started
    November 19, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0106-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Lots / codes
    a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25
    Distribution
    Nationwide.
    Quantity
    209,376 bottles
    Recall started
    November 19, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0105-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
    Lots / codes
    Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025
    Distribution
    PA, OH, PR
    Quantity
    8,561 bottles
    Recall started
    November 14, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0101-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint L…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
    Lots / codes
    a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
    Distribution
    PA, OH, PR
    Quantity
    23,490 bottles
    Recall started
    November 14, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0100-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

    Amerisource Health Services LLC · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
    Lots / codes
    Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025
    Distribution
    PA, OH, PR
    Quantity
    37,916 bottles
    Recall started
    November 14, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0099-2025
  • Class II Completed

    Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot #: 220128, Exp. Date 12/2024
    Distribution
    Product was distributed nationwide within the United States
    Quantity
    7,107 bottles
    Recall started
    October 10, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0009-2025
  • Class II Terminated

    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Pack…

    Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

    Golden State Medical Supply Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
    Lots / codes
    Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
    Distribution
    Nationwide in the U.S.
    Quantity
    21,655 (30 count bottle), 34,149 (90 count bottle)
    Recall started
    May 13, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0568-2024
  • Class II Terminated

    Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 0792…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
    Lots / codes
    Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    165,678, 90-count bottles
    Recall started
    May 17, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0562-2024
  • Class II Ongoing

    Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Preferred Pharmaceuticals, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: J2022G, Exp: 01/01/2025
    Distribution
    Product distributed to CA, FL, OK, KS and CT
    Quantity
    66 bottles of 30 tablets
    Recall started
    May 10, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0505-2024
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
    Lots / codes
    230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025
    Distribution
    US Nationwide.
    Quantity
    281,554/90 count bottles
    Recall started
    April 29, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0484-2024
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
    Lots / codes
    220456: Exp. Feb 2025
    Distribution
    US Nationwide.
    Quantity
    7,188/ 500 count bottles
    Recall started
    April 29, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0483-2024
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
    Lots / codes
    220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
    Distribution
    US Nationwide.
    Quantity
    281,554/90 & 1000 count bottles
    Recall started
    April 29, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0482-2024

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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