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 65 of 672
Recall # Product Firm Status Classification Report date
D-0787-2023 Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0812-2023 IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0790-2023 Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0841-2023 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 Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0827-2023 Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0849-2023 Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0814-2023 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 Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0776-2023 HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2 SSM Health Care St. Louis DBA SSM St. Clare Health Center Ongoing Class II Jun 7, 2023
D-0850-2023 Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0861-2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 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-0857-2023 Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0860-2023 Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0775-2023 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. Denison Pharmaceuticals, LLC Ongoing Class II Jun 7, 2023
D-0836-2023 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 Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0800-2023 Diuril (chlorothiazide sodium) Injection, 500mg/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-0788-2023 AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0804-2023 Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0801-2023 DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0772-2023 Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. Denison Pharmaceuticals, LLC Ongoing Class II Jun 7, 2023
D-0793-2023 Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0848-2023 Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0851-2023 Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0774-2023 Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02 Denison Pharmaceuticals, LLC Ongoing Class II Jun 7, 2023
D-0864-2023 Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0859-2023 Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023