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-0160-2026 | 08-27-2025 | 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 3,178 bottles | Class II | Ongoing |
| D-0162-2026 | 08-27-2025 | DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 1,480 packets | Class II | Ongoing |
| D-0172-2026 | 08-27-2025 | PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 16,006 units | Class II | Ongoing |
| D-0170-2026 | 08-27-2025 | Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 57,837 units | Class II | Ongoing |
| D-0174-2026 | 08-27-2025 | Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 37,272 tubes | Class II | Ongoing |
| D-0175-2026 | 08-27-2025 | Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 57,041 units | Class II | Ongoing |
| D-0161-2026 | 08-27-2025 | DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / | Class II | Ongoing |
| D-0177-2026 | 08-27-2025 | UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 37,379 spray bottles | Class II | Ongoing |
| D-0169-2026 | 08-27-2025 | Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 8,378 containers | Class II | Ongoing |
| D-0163-2026 | 08-27-2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 7,736 tubes | Class II | Ongoing |
| D-0165-2026 | 08-27-2025 | DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 2,389 bottles | Class II | Ongoing |
| D-0173-2026 | 08-27-2025 | PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 381,619 units | Class II | Ongoing |
| D-0171-2026 | 08-27-2025 | McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233. Package NDCs: 68599-6202-1; 68599-6202-2; 68599-6202-4; 68599-6203-1; 68599-6203-4 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 5,876 units | Class II | Ongoing |
| D-0653-2025 | 08-26-2025 | 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60. Package NDCs: 0264-7388-50; 0264-7388-60 | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | B BRAUN MEDICAL INC / 16,228 3000 mL bags | Class II | Ongoing |
| D-0652-2025 | 08-26-2025 | STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60. Package NDCs: 0264-7385-50; 0264-7385-60 | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | B BRAUN MEDICAL INC / 26,316 3000 mL bags | Class II | Ongoing |
| D-0661-2025 | 08-25-2025 | TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14 Package NDCs: 36800-589-14; 36800-589-72; 36800-589-43; 36800-589-45 | Cross Contamination with Other Products. | Consumer Product Partners, LLC / 60 bottles | Class III | Ongoing |
| D-0643-2025 | 08-25-2025 | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15 Package NDCs: 50268-162-11; 50268-162-15; 50268-163-11; 50268-163-15; 50268-164-11; 50268-164-15; 50268-165-11; 50268-165-15; 50268-166-11; 50268-166-12 | Presence of a foreign substance. | AvKARE / 1512 cartons | Class II | Ongoing |
| D-0644-2025 | 08-25-2025 | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15 Package NDCs: 50268-162-11; 50268-162-15; 50268-163-11; 50268-163-15; 50268-164-11; 50268-164-15; 50268-165-11; 50268-165-15; 50268-166-11; 50268-166-12 | Presence of a foreign substance. | AvKARE / 2003 cartons | Class II | Ongoing |
| D-0660-2025 | 08-25-2025 | Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14 Package NDCs: 30142-810-72; 30142-810-43; 30142-810-45; 30142-810-14 | Cross Contamination with Other Products. | Consumer Product Partners, LLC / 1860 bottles | Class III | Ongoing |
| D-0641-2025 | 08-22-2025 | Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757. | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64. | GRACE & FIRE PTY LTD / 44,497 tubes | Class II | Ongoing |
| D-0640-2025 | 08-22-2025 | Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808. | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64. | GRACE & FIRE PTY LTD / 49,275 tubes | Class II | Ongoing |
| D-0594-2025 | 08-20-2025 | Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61 Package NDCs: 0904-7305-61; 0904-7306-61; 0904-7307-61; 0904-7308-61 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 26,628 cartons | Class II | Ongoing |
| D-0596-2025 | 08-20-2025 | Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60. Package NDCs: 36000-306-60; 36000-372-40 | Discoloration | Baxter Healthcare Corporation / 13,000 containers | Class II | Ongoing |
| D-0654-2025 | 08-20-2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203. Package NDCs: 51655-307-20; 51655-307-29; 51655-307-53; 51655-307-84; 51655-307-87 | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Northwind Pharmaceuticals LLC / a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles | Class II | Ongoing |
| D-0674-2025 | 08-19-2025 | READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25 Package NDCs: 53329-939-04; 53329-939-06; 53329-939-08; 53329-939-23; 53329-939-25; 53329-939-69; 53329-939-13 | Subpotent drug | Medline Industries, LP / 2,680 bottles | Class III | Ongoing |
| D-0642-2025 | 08-19-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37. Package NDCs: 0527-0760-37; 0527-0761-37; 0527-0762-37; 0527-0763-37; 0527-0764-37; 0527-0765-37; 0527-0766-37 | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg. | Lannett Company Inc. / 4,848 bottles | Class II | Completed |
| D-0619-2025 | 08-18-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1. Package NDCs: 69238-1054-1; 69238-1056-1; 69238-1058-1; 69238-1060-1; 69238-1062-1 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amneal Pharmaceuticals, LLC / 3,363 100-count bottles | Class II | Ongoing |
| D-0618-2025 | 08-18-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1. Package NDCs: 69238-1054-1; 69238-1056-1; 69238-1058-1; 69238-1060-1; 69238-1062-1 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amneal Pharmaceuticals, LLC / 14,923 100-count bottles | Class II | Ongoing |
| D-0627-2025 | 08-18-2025 | Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 Package NDCs: 0264-7750-07 | Presence of Particulate Matter | B BRAUN MEDICAL INC / 46,032 containers | Class I | Ongoing |
| D-0615-2025 | 08-18-2025 | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Package NDCs: 65162-271-05; 65162-271-10; 65162-271-50; 65162-271-11; 65162-272-01; 65162-272-24; 65162-272-10; 65162-272-25; 65162-272-50 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amneal Pharmaceuticals, LLC / 60,072 100-count, 73,054 500-count bottles | Class II | Ongoing |
| D-0616-2025 | 08-18-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1. Package NDCs: 69238-1054-1; 69238-1056-1; 69238-1058-1; 69238-1060-1; 69238-1062-1 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amneal Pharmaceuticals, LLC / 7,228 100-count bottles | Class II | Ongoing |
| D-0617-2025 | 08-18-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1. Package NDCs: 69238-1054-1; 69238-1056-1; 69238-1058-1; 69238-1060-1; 69238-1062-1 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amneal Pharmaceuticals, LLC / 13,130 100-count bottles | Class II | Ongoing |
| D-0628-2025 | 08-18-2025 | 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 Package NDCs: 0264-7800-09 | Presence of Particulate Matter. | B BRAUN MEDICAL INC / 47,148 containers | Class I | Ongoing |
| D-0626-2025 | 08-13-2025 | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67 Package NDCs: 0781-6186-67 | Temperature Abuse | Sandoz Inc / 1,680 bottles | Class II | Ongoing |
| D-0595-2025 | 08-12-2025 | Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04 Package NDCs: 72578-102-04 | Discoloration | VIONA PHARMACEUTICALS INC / 3960 bottles | Class II | Ongoing |
| D-0599-2025 | 08-11-2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37 Package NDCs: 0527-4661-37; 0527-4662-37; 0527-4663-37; 0527-4664-37; 0527-4665-37; 0527-4666-37; 0527-4667-37 | Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. | Lannett Company Inc. / 8544 bottles | Class II | Terminated |
| D-0583-2025 | 08-08-2025 | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01 Package NDCs: 68462-380-01; 68462-380-05; 68462-356-01; 68462-356-05 | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria. | Glenmark Pharmaceuticals Inc., USA / 22,656 bottles | Class II | Ongoing |
| D-0621-2025 | 08-08-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10 Package NDCs: 82009-029-05; 82009-030-10; 82009-032-10; 82009-031-30; 82009-031-90 | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Breckenridge Pharmaceutical, Inc. / 3,591 bottles | Class II | Ongoing |
| D-0578-2025 | 08-07-2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Glenmark Pharmaceuticals Inc., USA / 6,432 bottles | Class II | Ongoing |
| D-0577-2025 | 08-07-2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Glenmark Pharmaceuticals Inc., USA / 44,328 bottles | Class II | Ongoing |
| D-0579-2025 | 08-07-2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Glenmark Pharmaceuticals Inc., USA / 4,800 bottles | Class II | Ongoing |
| D-0588-2025 | 08-06-2025 | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | Glenmark Pharmaceuticals Inc., USA / 14,976 bottles | Class II | Ongoing |
| D-0587-2025 | 08-06-2025 | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | Glenmark Pharmaceuticals Inc., USA / 17, 496 bottles | Class II | Ongoing |
| D-0581-2025 | 08-06-2025 | Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Westminster Pharmaceuticals LLC / 16,672 1000-count bottles | Class II | Ongoing |
| D-0582-2025 | 08-06-2025 | Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Westminster Pharmaceuticals LLC / 4,456 1000-count bottles | Class II | Ongoing |
| D-0597-2025 | 08-05-2025 | Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01 Package NDCs: 55154-3540-5; 55154-3541-5; 55154-3542-5; 55154-3543-5; 55154-3544-5; 0781-3238-01; 0781-3238-63; 0781-3246-02; 0781-3246-64; 0781-3256-03; 0781-3256-66; 0781-3262-04; 0781-3262-68; 0781-3268-05; 0781-3268-69; 0781-3298-04; 0781-3298-68; 0781-3299-05; 0781-3299-69 | Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL | Cardinal Health Inc. / 10 bags | Class II | Ongoing |
| D-0574-2025 | 08-05-2025 | Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01 Package NDCs: 53489-143-01; 53489-143-05; 53489-143-10; 53489-328-07; 53489-328-02; 53489-328-06; 53489-328-01; 53489-328-03; 53489-328-05; 53489-328-10; 53489-329-07; 53489-329-02; 53489-329-06; 53489-329-01; 53489-329-03; 53489-329-05; 53489-329-10 | Presence of foreign substance: identified as aluminum. | SUN PHARMACEUTICAL INDUSTRIES INC / 11,328 bottles | Class II | Ongoing |
| D-0592-2025 | 08-05-2025 | Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2 | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton | Haleon US Holdings LLC / 46,692 tubes | Class III | Ongoing |
| D-0586-2025 | 08-04-2025 | 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00. Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | B BRAUN MEDICAL INC / 23,100 containers | Class II | Ongoing |
| D-0590-2025 | 08-04-2025 | Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10. | Lack of Assurance of Sterility. | PFIZER INC / 49,620 vials | Class II | Ongoing |
| D-0585-2025 | 08-04-2025 | Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00. Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | B BRAUN MEDICAL INC / 74,088 containers | Class II | Ongoing |
| D-0591-2025 | 08-04-2025 | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14. Package NDCs: 0409-4916-24; 0409-4916-14; 0409-6637-24; 0409-6637-14; 00409-6637-14 | Lack of Assurance of Sterility. | PFIZER INC / 15,750 vials | Class II | Ongoing |
| D-0057-2026 | 07-30-2025 | L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 161 | Class II | Ongoing |
| D-0061-2026 | 07-30-2025 | Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 45 | Class II | Ongoing |
| D-0046-2026 | 07-30-2025 | Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0073-2026 | 07-30-2025 | EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0040-2026 | 07-30-2025 | Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 30 | Class II | Ongoing |
| D-0041-2026 | 07-30-2025 | Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 1550 | Class II | Ongoing |
| D-0090-2026 | 07-30-2025 | Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0079-2026 | 07-30-2025 | Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0074-2026 | 07-30-2025 | Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0043-2026 | 07-30-2025 | B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0065-2026 | 07-30-2025 | NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0066-2026 | 07-30-2025 | Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 294 | Class II | Ongoing |
| D-0038-2026 | 07-30-2025 | Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 17 | Class II | Ongoing |
| D-0060-2026 | 07-30-2025 | Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 478 | Class II | Ongoing |
| D-0058-2026 | 07-30-2025 | L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 15 | Class II | Ongoing |
| D-0089-2026 | 07-30-2025 | Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0087-2026 | 07-30-2025 | Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0064-2026 | 07-30-2025 | N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 85 | Class II | Ongoing |
| D-0039-2026 | 07-30-2025 | Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 235 | Class II | Ongoing |
| D-0069-2026 | 07-30-2025 | Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 339 | Class II | Ongoing |
| D-0091-2026 | 07-30-2025 | Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0094-2026 | 07-30-2025 | NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Microbial Contamination of Sterile Products: elevated endotoxin levels | GenoGenix LLC / | Class I | Ongoing |
| D-0082-2026 | 07-30-2025 | Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0571-2025 | 07-30-2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55. Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 6 units | Class II | Ongoing |
| D-0042-2026 | 07-30-2025 | B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 25 | Class II | Ongoing |
| D-0071-2026 | 07-30-2025 | Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0048-2026 | 07-30-2025 | Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 296 | Class II | Ongoing |
| D-0070-2026 | 07-30-2025 | Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 467 | Class II | Ongoing |
| D-0045-2026 | 07-30-2025 | B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0086-2026 | 07-30-2025 | BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI). | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0083-2026 | 07-30-2025 | Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0068-2026 | 07-30-2025 | Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 12 | Class II | Ongoing |
| D-0044-2026 | 07-30-2025 | B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 35 | Class II | Ongoing |
| D-0077-2026 | 07-30-2025 | Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0085-2026 | 07-30-2025 | BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0055-2026 | 07-30-2025 | L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 53 | Class II | Ongoing |
| D-0054-2026 | 07-30-2025 | Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 32 | Class II | Ongoing |
| D-0088-2026 | 07-30-2025 | Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0067-2026 | 07-30-2025 | Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 166 | Class II | Ongoing |
| D-0093-2026 | 07-30-2025 | Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0052-2026 | 07-30-2025 | Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0072-2026 | 07-30-2025 | CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0059-2026 | 07-30-2025 | Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 172 | Class II | Ongoing |
| D-0049-2026 | 07-30-2025 | Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 184 | Class II | Ongoing |
| D-0084-2026 | 07-30-2025 | Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0076-2026 | 07-30-2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0078-2026 | 07-30-2025 | Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0080-2026 | 07-30-2025 | pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
