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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.

311 recalls

  • Class II Terminated

    VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 1223049049 Exp 12/28/23
    Distribution
    Nationwide in the USA
    Quantity
    368 bags
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0425-2024
  • Class II Terminated

    Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC · Sodium Acetate Anhydrous

    Lots, distribution and details
    Lots / codes
    Lot #: 1223048444 Exp 11/20/23; 1223049011 Exp 12/12/23; 1223049673 Exp 01/09/24; 1223049771 Exp 01/12/24
    Distribution
    Nationwide in the USA
    Quantity
    9,624 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0422-2024
  • Class II Terminated

    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 7000…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)
    Lots / codes
    Lot #: 1223048610 Exp 04/10/24; 1223048611 Exp 04/10/24; 1223048726 Exp 04/13/24; 1223050163 Exp 06/12/24
    Distribution
    Nationwide in the USA
    Quantity
    2,427 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0421-2024
  • Class II Terminated

    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
    Lots / codes
    Lot #: 1223045974 Exp 12/18/23; 1223046535 Exp 01/11/24; 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067, Exp 04/06/2024; 1223048792, Exp 04/17/2024.
    Distribution
    Nationwide in the USA
    Quantity
    3,671 syringes, expanded 1,911 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0420-2024
  • Class II Terminated

    PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 1223050005 Exp 01/13/24
    Distribution
    Nationwide in the USA
    Quantity
    400 bags
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0419-2024
  • Class II Terminated

    PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
    Lots / codes
    Lot #: 1223045040 Exp 11/13/23, 1223046397 Exp 01/06/24, 1223046505 Exp 01/10/24, 1223047254 Exp 02/08/24, 1223047436 Exp 02/15/24, 1223047938 Exp 03/13/24, 1223049150 Exp 05/02/24, 1223049300 Exp 05/09/24, Expanded Lot #: 1223048569, Exp 04/06/2024; 1223049600, Exp 05/19/2024
    Distribution
    Nationwide in the USA
    Quantity
    10,017 syringes, expanded 2579 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0418-2024
  • Class II Terminated

    PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp 02/24/24; 1223047780 Exp 03/07/24; 1223047859 Exp 03/08/24; 1223048119 Exp 03/20/24; 1223048183 Exp 03/22/24; 1223048837 Exp 04/18/24; 1223048838 Exp 04/18/24; 1223048982 Exp 04/24/24; 1223049144 Exp 05/02/24; 1223049145 Exp 05/02/24; 1223049147 Exp 05/02/24; 1223049821 Exp 05/30/24 Expanded Lot #: 1223048037, Exp 03/16/2024; 1223048047, Exp 03/17/2024; 1223049146, 1223049149, Exp 05/02/2024; 1223049373, Exp 05/10/2024; 1223048909, Exp 04/20/2024; 1223048696, Exp 04/12/2024; 1223050181, Exp 06/12/2024
    Distribution
    Nationwide in the USA
    Quantity
    5,948 syringes, expanded 2,102 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0417-2024
  • Class II Terminated

    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 7000…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
    Lots / codes
    Lot #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24
    Distribution
    Nationwide in the USA
    Quantity
    1,118 syringes in kits
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0416-2024
  • Class II Terminated

    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 700040…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
    Lots / codes
    Lot #: 1223045053 Exp 11/15/23; 1223046179 Exp 12/28/23; 1223047477 Exp 02/16/24; 1223047602 Exp 02/22/24; 1223047971 Exp 03/14/24; 1223048269 Exp 03/27/24 Expanded lot#: 1223048181, exp. date 03/22/2024
    Distribution
    Nationwide in the USA
    Quantity
    7,198 syringes; expanded 1,289 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0415-2024
  • Class II Terminated

    PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 700…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
    Lots / codes
    Lot #: 1223045536 Exp 12/06/23; 1223045710 Exp 12/10/23; 1223046574 Exp 01/12/24; 1223047579 Exp 02/21/24; 1223047764 Exp 03/06/24; 1223048363 Exp 03/30/24; 1223048364 Exp 03/30/24; 1223048566 Exp 04/06/24; 1223048573 Exp 04/07/24; 1223048574 Exp 04/07/24; 1223048643 Exp 04/11/24; 1223048697 Exp 04/12/24; 1223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/2024; 1223048395, 1223048397, Exp 03/27/2024; 1223049980, Exp 06/05/2024
    Distribution
    Nationwide in the USA
    Quantity
    33,072 syringes; expanded 9,041 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0414-2024
  • Class II Terminated

    Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Lots / codes
    Lot#: 1223044958 Exp 11/10/23; 1223045436 Exp 11/30/23; 1223046132 Exp 12/28/23; 1223046385 Exp 01/06/24; 1223048807 Exp 04/17/24; 1223049030 Exp 04/26/24 Expanded Recall lots: 1223049328, Exp 05/10/2024;1223048948, Exp 04/21/2024; 1223048631, Exp 04/10/2024; 1223050389, Exp 06/21/2024.
    Distribution
    Nationwide in the USA
    Quantity
    1,508 bags; expanded 1,015 bags
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0412-2024
  • Class II Terminated

    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
    Lots / codes
    Lot#: 1223048258 Exp 11/10/23; 1223048890 Exp 12/07/23; 1223049134 Exp 12/19/23
    Distribution
    Nationwide in the USA
    Quantity
    909 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0410-2024
  • Class II Terminated

    HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Cod…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
    Lots / codes
    Lot #: 1223048357 Exp 11/15/23; 1223048461 EXP 11/20/23; 1223048486 EXP 11/21/23; 1223048694 EXP 12/01/23; 1223048865 EXP 12/06/23; 1223048967 EXP 12/11/23; 1223049098 EXP 12/15/23; 1223049133 EXP 12/19/23; 1223049175 EXP 12/20/23; 1223049268 EXP 12/25/23; 1223049457 EXP 01/01/24; 1223049561 EXP 01/04/24; 1223049604 EXP 01/05/24; 1223049648 EXP 01/09/24; 1223049870 EXP 01/17/24; 1223049942 EXP 01/19/24; 1223049973 EXP 01/23/24; 1223050060 EXP 01/25/24;
    Distribution
    Nationwide in the USA
    Quantity
    5392 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0409-2024
  • Class II Terminated

    HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 700403031…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
    Lots / codes
    Lot #: 1223048491 Exp 11/21/23
    Distribution
    Nationwide in the USA
    Quantity
    399 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0408-2024
  • Class II Terminated

    HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
    Lots / codes
    Lot#: 1223048801 Exp 12/04/23; 1223049225 Exp 12/21/23; 1223049264 Exp 12/25/23; 1223049291 Exp 12/26/23; 1223049726 exp 01/11/24
    Distribution
    Nationwide in the USA
    Quantity
    1,023 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0407-2024
  • Class II Terminated

    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
    Lots / codes
    Lot #: 1223048451 Exp 11/20/23; 1223048923 Exp 12/07/23; 1223049097 Exp 12/15/23; 1223049129 Exp 12/19/23;
    Distribution
    Nationwide in the USA
    Quantity
    1,425 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0406-2024
  • Class II Terminated

    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar C…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
    Lots / codes
    Lot #: 1223048530, Exp 11/22/23; 1223048692 Exp 11/29/23; 1223048739 EXP 11/30/23; 1223048826 Exp 12/05/23; 1223048963 Exp 12/08/23; 1223048964 EXP 12/11/23; 1223049111 Exp 12/15/23; 1223049128 Exp12/19/23; 1223049210 EXP 12/21/23; 1223049234 Exp 12/22/23; 1223049257 Exp 12/22/23; 1223049322 Exp 12/27/23; 1223049416 Exp 12/28/23; 1223049528 Exp 01/03/24; 1223049559 Exp 01/04/24; 1223049614 Exp 01/05/24; 1223049632 Exp 01/08/24; 1223049725 Exp 01/11/24; 1223049792 Exp 01/15/24; 1223049793 Exp 01/15/24; 1223049905 Exp 01/19/24; 1223050029 Exp 1/24/24; 1223050061 Exp 01/25/24; 1223050179 Exp 01/29/24
    Distribution
    Nationwide in the USA
    Quantity
    5,734 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0405-2024
  • Class II Terminated

    HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 1223049529, Exp 01/03/24
    Distribution
    Nationwide in the USA
    Quantity
    256 cassettes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0404-2024
  • Class II Terminated

    fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Product
    fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
    Lots / codes
    Lot #: 1223048959, Exp 12/11/23; 1223049009, Exp 12/12/23; 1223049170, Exp 12/20/23; 1223049245, Exp 12/22/23
    Distribution
    Nationwide in the USA
    Quantity
    500 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0403-2024
  • Class II Terminated

    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.,…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC · Fentanyl

    Lots, distribution and details
    Product
    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
    Lots / codes
    Lot #: 1223048722, Exp 11/29/23; 1223049096, Exp 12/15/23
    Distribution
    Nationwide in the USA
    Quantity
    130 cassettes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0401-2024
  • Class II Terminated

    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.,…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC · Fentanyl

    Lots, distribution and details
    Product
    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
    Lots / codes
    Lot #: 1223049261, Exp 12/25/23; 1223049724, Exp 01/11/24
    Distribution
    Nationwide in the USA
    Quantity
    412 cassettes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0400-2024
  • Class II Terminated

    fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC · Fentanyl

    Lots, distribution and details
    Product
    fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
    Lots / codes
    Lot #: 1223049125, Exp 12/04/23
    Distribution
    Nationwide in the USA
    Quantity
    324 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0399-2024
  • Class II Terminated

    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC · Fentanyl

    Lots, distribution and details
    Product
    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
    Lots / codes
    Lot #: 1223049754, Exp 01/12/24; 1223049992, Exp 01/23/24; 1223050066, Exp 01/25/24
    Distribution
    Nationwide in the USA
    Quantity
    613 Cassettes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0398-2024
  • Class II Terminated

    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 0609…

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC · Fentanyl

    Lots, distribution and details
    Product
    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
    Lots / codes
    Lot #: 1223048855, Exp 12/6/23
    Distribution
    Nationwide in the USA
    Quantity
    242 bags
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0397-2024
  • Class II Terminated

    fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940

    Reason: Lack of Assurance of Sterility

    SCA Pharmaceuticals, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 1223045757, Exp 12/27/23; 1223049716, Exp 5/25/24
    Distribution
    Nationwide in the USA
    Quantity
    548 bags
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0395-2024

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 November 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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