Drug Enforcements

Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.

Total records

16,790

Most recent report

September 24, 2025

Last updated

September 30, 2025

Drug Enforcement Records

Sorted by most recent report date.

Back to datasets Page 64 of 672
Recall # Product Firm Status Classification Report date
D-0816-2023 Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0780-2023 Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0807-2023 Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0797-2023 Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0823-2023 Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0779-2023 Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0802-2023 Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0843-2023 Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0795-2023 Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0863-2023 Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0785-2023 Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0794-2023 Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0778-2023 Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25 New England Life Care, Inc. dba Advanced Compounding Solutions Terminated Class III Jun 7, 2023
D-0856-2023 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 Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0829-2023 Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0846-2023 Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0826-2023 Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0815-2023 Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0791-2023 Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0799-2023 Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0824-2023 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0830-2023 Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0808-2023 Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0825-2023 Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0819-2023 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 Akorn, Inc. Ongoing Class II Jun 7, 2023