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 66 of 672
Recall # Product Firm Status Classification Report date
D-0781-2023 Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0813-2023 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0789-2023 Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0839-2023 Proparacaine HCl Ophthalmic Solution, USP 0.5%, 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-0828-2023 Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0862-2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 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-0806-2023 Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0773-2023 Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240. Denison Pharmaceuticals, LLC Ongoing Class II Jun 7, 2023
D-0835-2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 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-0858-2023 Calcitriol Injection 2 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-0796-2023 Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0817-2023 Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0840-2023 Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0833-2023 Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0809-2023 HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0854-2023 Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0803-2023 Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0821-2023 Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0820-2023 Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Akorn, Inc. Ongoing Class II Jun 7, 2023
D-0759-2023 Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories Amerisource Health Services LLC Terminated Class II May 31, 2023
D-0708-2023 oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1. Central Admixture Pharmacy Services, Inc. Terminated Class II May 31, 2023
D-0725-2023 vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1. Central Admixture Pharmacy Services, Inc. Terminated Class II May 31, 2023
D-0726-2023 heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1. Central Admixture Pharmacy Services, Inc. Terminated Class II May 31, 2023
D-0661-2023 Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1. Central Admixture Pharmacy Services, Inc. Terminated Class II May 31, 2023
D-0741-2023 tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2. Central Admixture Pharmacy Services, Inc. Terminated Class II May 31, 2023