Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0796-2023 | 04-26-2023 | Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0858-2023 | 04-26-2023 | Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0835-2023 | 04-26-2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0806-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0828-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0789-2023 | 04-26-2023 | Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0862-2023 | 04-26-2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0817-2023 | 04-26-2023 | Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0839-2023 | 04-26-2023 | Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0781-2023 | 04-26-2023 | Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0859-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0813-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0820-2023 | 04-26-2023 | Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0821-2023 | 04-26-2023 | Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0803-2023 | 04-26-2023 | Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0790-2023 | 04-26-2023 | Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0787-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0825-2023 | 04-26-2023 | Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0830-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0829-2023 | 04-26-2023 | Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0823-2023 | 04-26-2023 | Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0807-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0842-2023 | 04-26-2023 | Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0852-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0847-2023 | 04-26-2023 | Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0853-2023 | 04-26-2023 | Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0831-2023 | 04-26-2023 | Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0799-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0785-2023 | 04-26-2023 | Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0863-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0826-2023 | 04-26-2023 | Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0843-2023 | 04-26-2023 | Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0846-2023 | 04-26-2023 | Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0815-2023 | 04-26-2023 | Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0856-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0812-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0819-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0791-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0808-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0824-2023 | 04-26-2023 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0845-2023 | 04-26-2023 | Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0855-2023 | 04-26-2023 | Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0838-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0832-2023 | 04-26-2023 | Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0783-2023 | 04-26-2023 | Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0834-2023 | 04-26-2023 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0794-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0795-2023 | 04-26-2023 | Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0802-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0779-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0797-2023 | 04-26-2023 | Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0780-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0816-2023 | 04-26-2023 | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0810-2023 | 04-26-2023 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0818-2023 | 04-26-2023 | Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0844-2023 | 04-26-2023 | Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0792-2023 | 04-26-2023 | Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0786-2023 | 04-26-2023 | Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0784-2023 | 04-26-2023 | Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0805-2023 | 04-26-2023 | Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0822-2023 | 04-26-2023 | Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0837-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0798-2023 | 04-26-2023 | DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0811-2023 | 04-26-2023 | Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0782-2023 | 04-26-2023 | Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0841-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0827-2023 | 04-26-2023 | Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0814-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0849-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0860-2023 | 04-26-2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0857-2023 | 04-26-2023 | Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0861-2023 | 04-26-2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0850-2023 | 04-26-2023 | Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0836-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0788-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0800-2023 | 04-26-2023 | Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0848-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0793-2023 | 04-26-2023 | Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0801-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0804-2023 | 04-26-2023 | Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0864-2023 | 04-26-2023 | Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0851-2023 | 04-26-2023 | Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0572-2023 | 04-26-2023 | NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Gadget Island, Inc / 18 blister cards | Class I | Ongoing |
| D-0571-2023 | 04-26-2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Gadget Island, Inc / 628 blister cards | Class I | Ongoing |
| D-0573-2023 | 04-26-2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Gadget Island, Inc / 140 blister packs | Class I | Ongoing |
| D-0570-2023 | 04-24-2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61 Package NDCs: 0904-6823-61; 0904-7108-61 | Product mixup: one foreign tablet found in product. | The Harvard Drug Group / 3984 cartons | Class III | Terminated |
| D-0868-2023 | 04-20-2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01 Package NDCs: 52083-655-01 | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis / 9077 bottles | Class I | Terminated |
| D-0556-2023 | 04-20-2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA Package NDCs: 63629-8755-2; 63629-8755-1; 63629-8755-20 | Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. | Bryant Ranch Prepack, Inc. / 403 boxes | Class III | Ongoing |
| D-0562-2023 | 04-19-2023 | Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471. | Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications | Seatex LLC / 2880 containers | Class II | Ongoing |
| D-0569-2023 | 04-19-2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1 Package NDCs: 55566-1010-1 | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Sun Pharmaceutical Industries Ltd. / 24194 Prefilled Syringes | Class II | Terminated |
| D-0547-2023 | 04-13-2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 23,060 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0545-2023 | 04-13-2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 320,350 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0538-2023 | 04-13-2023 | C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402 | Lack of assurance of sterility. | Pharmacy Plus, Inc. dba Vital Care Compounder / 45 vials | Class II | Ongoing |
| D-0546-2023 | 04-13-2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 93,660 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0544-2023 | 04-13-2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc / 464,050 kg in bulk drums, boxes & sacks | Class III | Terminated |
| D-0575-2023 | 04-11-2023 | Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05 Package NDCs: 0024-5924-10; 0024-5925-01; 0024-5925-05; 0024-5925-00; 0024-5926-05 | Lack of Assurance of Sterility: Malformed crimped collar seal | Sanofi-Aventis U.S. LLC / 51,325 vials | Class II | Ongoing |
| D-0555-2023 | 04-10-2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44 | Subpotent Drug: Out of specification results for low potency was obtained. | SCA Pharmaceuticals / 73,312 containers | Class III | Terminated |
| D-0540-2023 | 04-07-2023 | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial). | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. | Methapharm Inc / 5377 cartons | Class II | Completed |
| D-0537-2023 | 04-06-2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8. | CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. | Pharma Nobis LLC / 69,615 bottles | Class II | Ongoing |
| D-0558-2023 | 04-06-2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90) | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 37 bottles | Class II | Terminated |
