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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.

1,094 recalls

  • Class II Ongoing

    Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Calcitriol

    Lots, distribution and details
    Product
    Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0858-2023
  • Class II Ongoing

    Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Amantadine Hydrochloride

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0857-2023
  • Class II Ongoing

    XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0856-2023
  • Class II Ongoing

    Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0855-2023
  • Class II Ongoing

    Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Valproic Acid

    Lots, distribution and details
    Product
    Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0854-2023
  • Class II Ongoing

    Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Tropicamide

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0853-2023
  • Class II Ongoing

    Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. – An Akorn Company- Lake Forest, IL 60045. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Trihexyphenidyl Hydrochloride

    Lots, distribution and details
    Product
    Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. – An Akorn Company- Lake Forest, IL 60045. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0852-2023
  • Class II Ongoing

    Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0846-2023
  • Class II Ongoing

    Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Sodium Acetate Anhydrous

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0845-2023
  • Class II Ongoing

    Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Rifampin

    Lots, distribution and details
    Product
    Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0841-2023
  • Class II Ongoing

    Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Rifampin

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0840-2023
  • Class II Ongoing

    Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Proparacaine Hydrochloride

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0839-2023
  • Class II Ongoing

    Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Promethazine Hydrochloride

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0838-2023
  • Class II Ongoing

    Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0837-2023
  • Class II Ongoing

    Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Prednisolone

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0836-2023
  • Class II Ongoing

    Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Pilocarpine Hydrochloride

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0835-2023
  • Class II Ongoing

    Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Oxcarbazepine

    Lots, distribution and details
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0834-2023
  • Class II Ongoing

    Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Megestrol Acetate

    Lots, distribution and details
    Product
    Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0827-2023
  • Class II Ongoing

    Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Product
    Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0826-2023
  • Class II Ongoing

    Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Lidocaine Hydrochloride

    Lots, distribution and details
    Product
    Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0824-2023
  • Class II Ongoing

    Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Levofloxacin

    Lots, distribution and details
    Product
    Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0819-2023
  • Class II Ongoing

    Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Levocarnitine

    Lots, distribution and details
    Product
    Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0817-2023
  • Class II Ongoing

    Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc.

    Lots, distribution and details
    Product
    Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0816-2023
  • Class II Ongoing

    Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Lactulose

    Lots, distribution and details
    Product
    Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0815-2023
  • Class II Ongoing

    Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Lactulose

    Lots, distribution and details
    Product
    Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0814-2023

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 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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