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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.

3 Class I (most serious) drug recalls reported in the last 30 days.

3,250 recalls

  • Class III Ongoing

    Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-1…

    Reason: Labeling; Incorrect NDC number on outer carton of product.

    Focus Health Group Inc

    Lots, distribution and details
    Product
    Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13
    Lots / codes
    Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
    Distribution
    Nationwide in the USA
    Quantity
    246 kits
    Recall started
    March 16, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0535-2023
  • Class III Ongoing

    MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02

    Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.

    Pfizer Inc. · Binimetinib

    Lots, distribution and details
    Product
    MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
    Lots / codes
    Lot W054586A, EXP 03/2026
    Distribution
    Nationwide in the USA
    Quantity
    1,926 Bottles
    Recall started
    March 8, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0532-2023
  • Class II Ongoing

    Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar…

    Reason: CGMP Deviations: Discoloration

    Hetero USA Inc · Pantoprazole

    Lots, distribution and details
    Product
    Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
    Lots / codes
    Lot #: PAN22542, Exp. Date: 9/2024
    Distribution
    Nationwide within the United States
    Quantity
    2,352 bottles
    Recall started
    March 14, 2023 (N/A)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0530-2023
  • Class II Ongoing

    Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Glimepiride

    Lots, distribution and details
    Lots / codes
    Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023.
    Distribution
    USA Nationwide
    Quantity
    15 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0527-2023
  • Class II Ongoing

    Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Tadalafil

    Lots, distribution and details
    Lots / codes
    Lot: C0822E, Exp 1/31/2024, F1121B, Exp 1/31/2024, G2721L, Exp 1/31/2024.
    Distribution
    USA Nationwide
    Quantity
    32 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0526-2023
  • Class II Ongoing

    Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durha…

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Simvastatin

    Lots, distribution and details
    Product
    Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
    Lots / codes
    a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp. Date: 10/31/2024, L1922A, Exp. Date: 2/28/2025; b) Lot: F2922S, Exp. Date: 8/31/2023, H0322G Exp. Date: 7/31/2023; c) Lot: A1322I, Exp. Date: 3/31/2023, H1122C, Exp. Date: 8/31/2024.
    Distribution
    USA Nationwide
    Quantity
    a) 88 Bottles, b) 3 Bottles, c) 175 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0525-2023
  • Class II Ongoing

    Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durha…

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Simvastatin

    Lots, distribution and details
    Product
    Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
    Lots / codes
    a) Lot: A0923R, Exp. Date: 2/28/2025, A1222K, B1822C, Exp. Date: 5/31/2024, C3022D, F2322V, Exp. Date: 6/30/2024, H1522H, Exp. Date: 8/31/2024, I1621O, Exp. Date: 1/31/2024, I2222G, J1822R, Exp. Date: 9/30/2024, L1621N, Exp. Date: 5/31/2024; b) Lot: F0822Q, Exp. Date: 6/30/2024, I0122J, Exp. Date: 8/31/2024, L0821C, Exp. Date: 5/31/2024; c) Lot: I1521P, Exp. Date: 1/31/2024, J1322R, Exp. Date: 9/30/2024, J1821H, Exp. Date: 2/29/2024.
    Distribution
    USA Nationwide
    Quantity
    a) 305 Bottles, b) 72 Bottles, c) 617 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0524-2023
  • Class II Ongoing

    Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Simvastatin

    Lots, distribution and details
    Lots / codes
    Lot: B0222S, Exp 2/29/2024; Lot: F1121B, G2721L, Exp 11/30/2023.
    Distribution
    USA Nationwide
    Quantity
    57 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0523-2023
  • Class II Ongoing

    Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Simvastatin

    Lots, distribution and details
    Lots / codes
    Lot: C2222P, D1522L, E3122D, G2522J, Exp 9/30/2023; Lot: J1222R, Exp 10/31/2023.
    Distribution
    USA Nationwide
    Quantity
    82 Bottles of 90 Tablets
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0522-2023
  • Class II Ongoing

    Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Pravastatin Sodium

    Lots, distribution and details
    Lots / codes
    Lot: F1021I; H3122J, Exp 4/30/2024
    Distribution
    USA Nationwide
    Quantity
    24 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0521-2023
  • Class II Ongoing

    Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Rosuvastatin

    Lots, distribution and details
    Lots / codes
    Lot: A1723C, Exp 8/31/2025; Lot: A1922B, Exp 6/30/2024; Lot: D0622M and Lot: F2922I, Exp 7/31/2024; Lot: G3021L, Exp 1/31/2024; Lot:H2622P & Lot: J0722C, Exp 10/31/2024.
    Distribution
    USA Nationwide
    Quantity
    264 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0520-2023
  • Class II Ongoing

    Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Rosuvastatin

    Lots, distribution and details
    Lots / codes
    a) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K0222N, Exp. Date: 6/30/2024; Lot: L2322D and Lot: L2822J, Exp. Date:7/31/2025.
    Distribution
    USA Nationwide
    Quantity
    a) 59 Bottles, b) 77 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0519-2023
  • Class II Ongoing

    Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Du…

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Montelukast Sodium

    Lots, distribution and details
    Product
    Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
    Lots / codes
    a) Lot: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025.
    Distribution
    USA Nationwide
    Quantity
    a) 266 Bottles, b) not reported, c) 216 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0518-2023
  • Class II Ongoing

    Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Glimepiride

    Lots, distribution and details
    Lots / codes
    Lot: D0122K, Exp. Date: 6/30/2024; Lot: I1422N, Exp. Date: 9/30/2024; Lot: I2721B, Exp. Date: 1/31/2024.
    Distribution
    USA Nationwide
    Quantity
    17 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0517-2023
  • Class II Ongoing

    Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Finasteride

    Lots, distribution and details
    Lots / codes
    a) Lot: A1321V, D0221J, Exp. Date:8/31/2023; Lot: A1322J, Exp. Date: 5/31/2024; Lot: F0221Q, I0121E, I1021R, J1122D, Exp. Date: 10/31/2023; b) Lot: B0422J, Exp. Date: 5/31/2024; Lot: C1721K, Exp. Date: 8/31/2023; Lot: K1022Q, Exp. Date:11/30/2024.
    Distribution
    USA Nationwide
    Quantity
    a) 135 Bottles, b) 24 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0516-2023
  • Class II Ongoing

    Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Doxazosin

    Lots, distribution and details
    Lots / codes
    Lot: L1522V, Exp 4/30/2025.
    Distribution
    USA Nationwide
    Quantity
    4 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0515-2023
  • Class II Ongoing

    Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Doxazosin

    Lots, distribution and details
    Lots / codes
    Lot: H3122K, Exp 5/31/2024.
    Distribution
    USA Nationwide
    Quantity
    3 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0514-2023
  • Class II Ongoing

    Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Clopidogrel

    Lots, distribution and details
    Lots / codes
    Lot: E0922W, G1222E, I0922W and K3022W Exp 10/31/2023.
    Distribution
    USA Nationwide
    Quantity
    72 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0513-2023
  • Class II Ongoing

    Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Atorvastatin Calcium

    Lots, distribution and details
    Lots / codes
    a) Lot: B1522B, Exp 4/30/2023; lot:C0222H, C0322B, Exp 5/31/2023; lot: E1022H, F13220, H2222P, Exp 6/30/2023; Lot: I1422V, K01220, Exp 12/31/2023; Lot: L2722H, Exp 3/31/2024; b) Lot:C0322B, Exp 5/31/2023; lot:H1122G, 12322Q, Exp 6/30/2023; lot: J1222U, Exp 12/31/2023.
    Distribution
    USA Nationwide
    Quantity
    a) 375 Bottles b) 323 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0512-2023
  • Class II Ongoing

    Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Atorvastatin Calcium

    Lots, distribution and details
    Lots / codes
    Lot #: A0523D, Exp 5/31/2024, F14220, Exp 7/31/2023, J0622Q; Exp 1/31/2024.
    Distribution
    USA Nationwide
    Quantity
    158 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0511-2023
  • Class II Ongoing

    Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.

    Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

    Direct Rx · Alprazolam

    Lots, distribution and details
    Lots / codes
    Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23
    Distribution
    Nationwide in the USA
    Quantity
    9 bottles
    Recall started
    March 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0509-2023
  • Class II Ongoing

    Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

    Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

    Direct Rx · Alprazolam

    Lots, distribution and details
    Lots / codes
    Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
    Distribution
    Nationwide in the USA
    Quantity
    349 bottles
    Recall started
    March 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0508-2023
  • Class II Ongoing

    Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.

    Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

    Direct Rx · Alprazolam

    Lots, distribution and details
    Lots / codes
    Lot: 11AP2219 Exp. 4/30/23
    Distribution
    Nationwide in the USA
    Quantity
    20 bottles
    Recall started
    March 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0507-2023
  • Class II Ongoing

    Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

    Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

    Ascend Laboratories, LLC · Dabigatran Etexilate

    Lots, distribution and details
    Product
    Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
    Lots / codes
    Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
    Distribution
    Nationwide in the USA.
    Quantity
    12,804 bottles
    Recall started
    March 14, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0534-2023
  • Class II Ongoing

    Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

    Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

    Ascend Laboratories, LLC · Dabigatran Etexilate

    Lots, distribution and details
    Lots / codes
    Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
    Distribution
    Nationwide in the USA.
    Quantity
    13,560 bottles
    Recall started
    March 14, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0533-2023

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 November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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