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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

    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), 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 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), 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 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    41,572 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-0307-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, M…

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

    Teva Pharmaceuticals USA

    Lots, distribution and details
    Product
    Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), 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 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    142,260 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-0306-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, M…

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

    Teva Pharmaceuticals USA · Amlodipine and Valsartan

    Lots, distribution and details
    Product
    Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), 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 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    75,883 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-0305-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel,…

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

    Teva Pharmaceuticals USA · Amlodipine and Valsartan

    Lots, distribution and details
    Product
    Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), 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 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012, 24X013
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    39,617 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-0304-2019
  • Class II Ongoing

    Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, M…

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

    Teva Pharmaceuticals USA · Amlodipine and Valsartan

    Lots, distribution and details
    Product
    Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 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 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024
    Distribution
    USA Nationwide including Puerto Rico.
    Quantity
    120,394 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-0303-2019

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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