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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0663-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 308 bags | Class II | Terminated |
| D-0727-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 5304 bags | Class II | Terminated |
| D-0720-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 27780 bags | Class II | Terminated |
| D-0681-2023 | 04-28-2023 | Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 690 syringes | Class II | Terminated |
| D-0719-2023 | 04-28-2023 | vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 13772 bags | Class II | Terminated |
| D-0660-2023 | 04-28-2023 | Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 544 bags | Class II | Terminated |
| D-0690-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0419-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 418 bags | Class II | Terminated |
| D-0715-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 6407 bags | Class II | Terminated |
| D-0657-2023 | 04-28-2023 | Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0014-2. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 24 bags | Class II | Terminated |
| D-0678-2023 | 04-28-2023 | Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 363 bags | Class II | Terminated |
| D-0755-2023 | 04-28-2023 | HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 1673 bags | Class II | Terminated |
| D-0724-2023 | 04-28-2023 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 14205 bags | Class II | Terminated |
| D-0666-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 613 bags | Class II | Terminated |
| D-0739-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 1300 bags | Class II | Terminated |
| D-0679-2023 | 04-28-2023 | Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 325 bags | Class II | Terminated |
| D-0749-2023 | 04-28-2023 | vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 4259 bags | Class II | Terminated |
| D-0732-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 5207 bags | Class II | Terminated |
| D-0680-2023 | 04-28-2023 | Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 79 bags | Class II | Terminated |
| D-0672-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 333 bags | Class II | Terminated |
| D-0717-2023 | 04-28-2023 | vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 4390 bags | Class II | Terminated |
| D-0726-2023 | 04-28-2023 | 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. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 3055 bags | Class II | Terminated |
| D-0656-2023 | 04-28-2023 | Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 144 bags | Class II | Terminated |
| D-0692-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 427 bags | Class II | Terminated |
| D-0753-2023 | 04-28-2023 | Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 1516 bags | Class II | Terminated |
| D-0655-2023 | 04-28-2023 | Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 12 bags | Class II | Terminated |
| D-0665-2023 | 04-28-2023 | Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 48 bags | Class II | Terminated |
| D-0741-2023 | 04-28-2023 | 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. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 225 syringes | Class II | Terminated |
| D-0738-2023 | 04-28-2023 | diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 3999 bags | Class II | Terminated |
| D-0730-2023 | 04-28-2023 | EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 2542 bags | Class II | Terminated |
| D-0694-2023 | 04-28-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0423-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 128 bags | Class II | Terminated |
| D-0676-2023 | 04-28-2023 | Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 52 bags | Class II | Terminated |
| D-0731-2023 | 04-28-2023 | heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. / 11117 bags | Class II | Terminated |
| D-0766-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 438 | Class III | Terminated |
| D-0770-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 3032 | Class III | Terminated |
| D-0768-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 1272 | Class III | Terminated |
| D-0767-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 397 | Class III | Terminated |
| D-0769-2023 | 04-27-2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28 | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc / 1908 | Class III | Terminated |
| D-0568-2023 | 04-26-2023 | Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6 Package NDCs: 60505-0823-0; 60505-0823-6 | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. | Apotex Corp. / 82,375 bottles | Class II | Completed |
| 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-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-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-0854-2023 | 04-26-2023 | Valproic Acid Oral Solution, USP, 250mg/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-0809-2023 | 04-26-2023 | 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 | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. / N/A | Class II | Ongoing |
| D-0833-2023 | 04-26-2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 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-0840-2023 | 04-26-2023 | Rifampin Capsules USP, 150 mg, 30-count 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
