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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 II Ongoing

    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15

    Reason: CGMP Deviations:

    Akorn, Inc. · Proparacaine Hydrochloride

    Lots, distribution and details
    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
    Lots / codes
    Lot: 0L53A, EXP 10/31/2022; 1J49A, EXP 8/31/2023;
    Distribution
    Nationwide in the USA
    Quantity
    23,026 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0154-2023
  • Class II Ongoing

    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

    Reason: CGMP Deviations:

    Akorn, Inc. · Proparacaine Hydrochloride

    Lots, distribution and details
    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    Lots / codes
    Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023
    Distribution
    Nationwide in the USA
    Quantity
    267,678 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0153-2023
  • Class II Ongoing

    PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

    Reason: CGMP Deviations:

    Akorn, Inc.

    Lots, distribution and details
    Product
    PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
    Lots / codes
    Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;
    Distribution
    Nationwide in the USA
    Quantity
    51,601 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0152-2023
  • Class II Ongoing

    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

    Reason: CGMP Deviations:

    Akorn, Inc. · Olopatadine Hydrochloride

    Lots, distribution and details
    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
    Lots / codes
    Lot: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;
    Distribution
    Nationwide in the USA
    Quantity
    121,176 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0151-2023
  • Class II Ongoing

    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012.…

    Reason: CGMP Deviations:

    Akorn, Inc. · Olopatadine Hydrochloride

    Lots, distribution and details
    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Lots / codes
    Lot: 1L16A, 1L17A, EXP 10/31/2023; 1M29A, EXP 11/30/2023; 2A05A, EXP 12/31/2023;
    Distribution
    Nationwide in the USA
    Quantity
    163,996 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0150-2023
  • Class II Ongoing

    Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12

    Reason: CGMP Deviations:

    Akorn, Inc. · Olopatadine Hydrochloride

    Lots, distribution and details
    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
    Lots / codes
    Lot: 0L48A, EXP 10/31/2022; 0L55A, EXP 10/31/2022; 1C75A, EXP 2/28/2023; 1E18A, 1E20A , EXP 4/30/2023;
    Distribution
    Nationwide in the USA
    Quantity
    173,928 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0149-2023
  • Class II Ongoing

    Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05

    Reason: CGMP Deviations:

    Akorn, Inc. · Olopatadine Hydrochloride

    Lots, distribution and details
    Product
    Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
    Lots / codes
    Lot: 1L03A, EXP 10/31/2023
    Distribution
    Nationwide in the USA
    Quantity
    1,752 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0148-2023
  • Class II Ongoing

    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

    Reason: CGMP Deviations:

    Akorn, Inc. · Olopatadine Hydrochloride

    Lots, distribution and details
    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
    Lots / codes
    Lot: Lot 1B41A, EXP 1/31/2023
    Distribution
    Nationwide in the USA
    Quantity
    31,073 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0147-2023
  • Class II Ongoing

    Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05

    Reason: CGMP Deviations:

    Akorn, Inc. · Ofloxacin

    Lots, distribution and details
    Lots / codes
    Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;
    Distribution
    Nationwide in the USA
    Quantity
    65,006 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0146-2023
  • Class II Ongoing

    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35

    Reason: CGMP Deviations:

    Akorn, Inc. · Neomycin and Polymyxin B Sulfates

    Lots, distribution and details
    Product
    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
    Lots / codes
    Lot: Lot 1K64A, EXP 9/30/2023
    Distribution
    Nationwide in the USA
    Quantity
    2,082 tubes
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0145-2023
  • Class II Ongoing

    Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

    Reason: CGMP Deviations:

    Akorn, Inc. · Moxifloxacin

    Lots, distribution and details
    Product
    Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
    Lots / codes
    Lot, Expiry: Lots 1E28A, exp 4/30/2023
    Distribution
    Nationwide in the USA
    Quantity
    2,563 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0144-2023
  • Class II Ongoing

    Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.

    Reason: CGMP Deviations:

    Akorn, Inc.

    Lots, distribution and details
    Product
    Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
    Lots / codes
    Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, EXP 8/31/2023; 0K15B, 0K15A, EXP 9/30/2023; 0L56B, EXP 10/31/2023; 1B20A, EXP 1/31/2024; 1C47A, 1C52A, EXP 2/29/2024; 1D84B,1D84A, EXP 3/31/2024; 1G61A, 1G64A, 1G72A, EXP 6/30/2024; 1J51A, 1J28A, EXP 8/31/2024; 1K63A, 1K69A, 1K73A, 1K69B, 1K69C, EXP 9/30/2024; 1L15B, EXP 10/31/2024; 2C08A,EXP 2/28/2025;
    Distribution
    Nationwide in the USA
    Quantity
    2,369,258 tubes
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0143-2023
  • Class II Ongoing

    Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

    Reason: CGMP Deviations:

    Akorn, Inc. · Levofloxacin

    Lots, distribution and details
    Product
    Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
    Lots / codes
    Lot # 1F43A, EXP 5/31/2/023
    Distribution
    Nationwide in the USA
    Quantity
    3108 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0142-2023
  • Class II Ongoing

    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Ako…

    Reason: CGMP Deviations:

    Akorn, Inc. · Ketorolac Tromethamine

    Lots, distribution and details
    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Lots / codes
    Lot: (a) 1A09A, EXP 12/31/2022; 1H01A, EXP 7/31/2023 ; (b) 1E32A, EXP 4/30/2023; 1F45A, EXP 5/31/2023; 1H99A, EXP 7/31/2023; 1K84A, EXP 9/30/2023; (c) 0L40A, EXP 10/31/2022; 1B38A, EXP 1/31/2023; 1E12A, EXP 4/30/2023; 1F41A, EXP 5/31/2023; 1G73A, 1G68A, EXP 6/30/2023; 1H08A, 1H12A, EXP 7/31/2023
    Distribution
    Nationwide in the USA
    Quantity
    314,543 10ml,3ml, 5ml bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0141-2023
  • Class II Ongoing

    GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12

    Reason: CGMP Deviations:

    Akorn, Inc.

    Lots, distribution and details
    Product
    GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
    Lots / codes
    Lot: 0C80A, EXP 2/28/2023; 0B71A, 1B32A, EXP 1/31/2023; 0C80B, EXP 2/28/2023; 0F68A, EXP 5/31/2023; 0G85A, 0G01A, 1G54A, 1G71A, EXP 6/30/2023; 0H32A, 0H47A, 1H75A, EXP 7/31/2023; 0K22A, EXP 9/30/2023; 0M90A, EXP 11/30/2023;
    Distribution
    Nationwide in the USA
    Quantity
    196,254 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0140-2023
  • Class II Ongoing

    Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31

    Reason: CGMP Deviations:

    Akorn, Inc. · Erythromycin

    Lots, distribution and details
    Product
    Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
    Lots / codes
    Lot: 1B14B, EXP 1/31/2023; 1C49A, 1C49B, 1C70A, EXP 2/28/2023; 1E09A, 1E34A, 1E34B, 1E09B, EXP 4/30/2023; 1F37C, 1F37A, 1F37B, EXP 5/31/2023; 1G58A, 1G57B, 1G58B, 1G66B, 1G66A, 1G57A, EXP 6/30/2023; 1H77B, 1H80A, 1H80B, 1H77A, EXP 7/31/2023; 1J24A, EXP 8/31/2023; 1K67B, 1K67A, 1K76A, 1K87B, 1K77A, 1K76B, 1K87A, 1K77B, EXP 9/30/2023; 1L90B, 1L90A, 1L92B, 1L92A, EXP 10/31/2023; 1M28A, 1M35A, 1M28B, EXP 11/30/2023; 2D20B, EXP 3/31/2024.
    Distribution
    Nationwide in the USA
    Quantity
    36,455 cartons
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0139-2023
  • Class II Ongoing

    ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

    Reason: CGMP Deviations:

    Akorn, Inc. · Erythromycin

    Lots, distribution and details
    Product
    ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
    Lots / codes
    Lot: 0L58A, EXP 10/31/2022; 1B21A, 1B31A, EXP 1/31/2023; 1C44A, 1C58A, 1C58B, EXP 2/28/2023; 1E13A, 1E24A, EXP 4/30/2023; 1C57A, EXP 2/28/2023; 1G60A, 1G62A, 1G63A, EXP 6/30/2023; 1J34B, 1J40A, 1J21A, EXP 8/31/2023; 1K74A, EXP 9/30/2023; 1L93A, 1L96B, 1L96A, EXP 10/31/2023; 1M25A, 1M24A, 1M31A, EXP 11/30/2023; 2A02A, 2A10A, EXP 12/31/2023; 2C07A, EXP 2/29/2024; 2D47A, EXP 3/31/2024; 2E50A, 2E51A, EXP 4/30/2024;
    Distribution
    Nationwide in the USA
    Quantity
    1,109,600 tubes
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0138-2023
  • Class II Ongoing

    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

    Reason: CGMP Deviations:

    Akorn, Inc. · Cromolyn Sodium

    Lots, distribution and details
    Product
    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
    Lots / codes
    Lot: 0G75A, 0G12A, EXP 6/30/2023; 0H50A, EXP 7/31/2023; 0J88A, EXP 8/31/2023; 1D98A, EXP 3/31/2024; 1E31A, EXP 4/30/2024; 1D97A, EXP 3/31/2024; 1H14A, EXP 7/31/2024;
    Distribution
    Nationwide in the USA
    Quantity
    188,550 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0137-2023
  • Class II Ongoing

    Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

    Reason: CGMP Deviations:

    Akorn, Inc. · Ciprofloxacin

    Lots, distribution and details
    Product
    Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
    Lots / codes
    Lot: Lot 1E22A, EXP 10/31/2022
    Distribution
    Nationwide in the USA
    Quantity
    1,584 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0136-2023
  • Class II Ongoing

    Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10

    Reason: CGMP Deviations:

    Akorn, Inc. · Betaxolol

    Lots, distribution and details
    Product
    Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
    Lots / codes
    Lot: 1A08A, EXP 12/31/2022
    Distribution
    Nationwide in the USA
    Quantity
    6,273 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0135-2023
  • Class II Ongoing

    Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12

    Reason: CGMP Deviations:

    Akorn, Inc.

    Lots, distribution and details
    Product
    Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
    Lots / codes
    Lot: 0L44A, 0L52A, 0L51A, 0L77A, 0L75A, EXP 10/31/2022; 0M02A, 0M01A, EXP 11/30/2022; 1C81A, EXP 2/28/2023; 1D02A, 1D03A, EXP 3/31/2023; 1E10A, 1E08A, 1E23A, 1E26A, 1E25A, 1E27A, 1E33A, EXP 4/30/2023; 1F46A, EXP 5/31/2023; 1G49A, 1G50A, 1G67A, EXP 6/30/2023; 1H04A, 1H74A,1H76A, 1H05A, 1H07A, 1H15A, 1H13A, 1H95A, EXP 7/31/2023; 1J44A, 1J20A, EXP 8/31/2023;
    Distribution
    Nationwide in the USA
    Quantity
    967,075 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0134-2023
  • Class II Ongoing

    Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35

    Reason: CGMP Deviations:

    Akorn, Inc.

    Lots, distribution and details
    Product
    Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
    Lots / codes
    Lot # 0A08B, EXP 12/31/2022; 0B63A, EXP 1/31/2023; 0C72A, EXP 2/28/2023; 0D14A, 0D19A, EXP 3/31/2023; 0F54A, EXP 5/31/2023; 0G80B, 0G09B, 0G97A, EXP 6/30/2023; 0J78A, EXP 8/31/2023; 0K23A, EXP 9/30/2023; 0L64A, EXP 10/31/2023;1B29A, EXP 1/31/2024; 1C59A, 1C53A, 1C72A,1C78A, EXP 2/29/2024; 1D87A, 1D89A, EXP 3/31/2024; 1G59A, 1G59B, EXP 6/30/2024; 1K60A, EXP 9/30/2024; 1J57A, EXP 8/31/2024; 1H86A, EXP 7/31/2024; 1K75A, EXP 9/30/2024; 1L12A, EXP 10/31/2024; 1M22A, EXP 11/30/2024
    Distribution
    Nationwide in the USA
    Quantity
    1,164,171 tubes
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0133-2023
  • Class II Ongoing

    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35

    Reason: CGMP Deviations:

    Akorn, Inc.

    Lots, distribution and details
    Product
    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
    Lots / codes
    Lot # 0G87A, EXP 06/30/2023
    Distribution
    Nationwide in the USA
    Quantity
    36,025 tubes
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0132-2023
  • Class II Ongoing

    Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

    Reason: Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

    Eugia US LLC · Acyclovir Sodium

    Lots, distribution and details
    Product
    Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
    Lots / codes
    Lot # AC22004, Expiry: 08/2023
    Distribution
    Nationwide in the USA
    Quantity
    45,250 vials
    Recall started
    December 28, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0095-2023
  • Class II Ongoing

    Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

    Reason: Failed Impurities/Degradation Specifications

    Aurolife Pharma, LLC · Glycopyrrolate

    Lots, distribution and details
    Lots / codes
    Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
    Distribution
    Nationwide in the USA and Puerto Rico.
    Quantity
    7344 bottles
    Recall started
    December 16, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0087-2023

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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