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-0667-2025 | 09-12-2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825. | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0026-2026 | 09-05-2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 1,041 cartons | Class III | Ongoing |
| D-0677-2025 | 09-05-2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. Package NDCs: 60505-1003-1; 60505-1003-2; 6050510031; 3605051003 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. / 493,468 bottles | Class II | Ongoing |
| D-0676-2025 | 09-05-2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL). Package NDCs: 60505-0589-1; 60505-0589-2; 60505-0589-3; 0036050505; 6050505892 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. / 151,034 bottles | Class II | Ongoing |
| D-0651-2025 | 09-05-2025 | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10. Package NDCs: 0781-3528-75; 0781-3528-10; 0781-3529-70; 0781-3529-10; 0781-3530-80; 0781-3530-10; 0030781352; 1068604062; 1068728143; 1068740996; 1070120033; 1068732564; 1068766116 | cGMP deviations: Temperature excursion during transportation. | Sandoz Inc / 6 vials | Class II | Ongoing |
| D-0656-2025 | 09-04-2025 | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 4344 bottles | Class II | Ongoing |
| D-0657-2025 | 09-04-2025 | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 4440 bottles | Class II | Ongoing |
| D-0636-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0634-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0658-2025 | 09-03-2025 | Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1 Package NDCs: 45567-0655-1 | Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. | SUN PHARMACEUTICAL INDUSTRIES INC / 1870 kits | Class II | Ongoing |
| D-0632-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0630-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0638-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0021-2026 | 09-03-2025 | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29. Package NDCs: 68462-318-84; 68462-318-29 | Failed Impurities/Degradation Specifications | Glenmark Pharmaceuticals Inc., USA / 26,928 packs | Class II | Ongoing |
| D-0633-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0635-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0637-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0639-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0631-2025 | 09-03-2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01 Package NDCs: 16714-047-01; 16714-048-01; 16714-049-01; 16714-050-01; 16714-051-01 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0625-2025 | 09-02-2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters). Package NDCs: 55154-7895-0; 0904-2725-61 | 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. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Ongoing |
| D-0624-2025 | 09-02-2025 | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61 Package NDCs: 0904-2725-61 | 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. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Ongoing |
| D-0007-2026 | 09-02-2025 | Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28 Package NDCs: 42291-565-28; 42291-565-84 | Failed Content Uniformity Specifications | AvKARE / 2192 cartons | Class II | Ongoing |
| D-0646-2025 | 08-29-2025 | bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226 | Lack of Assurance of Sterility | Fagron Compounding Services / 109,320 syringes | Class II | Ongoing |
| D-0645-2025 | 08-28-2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03 Package NDCs: 67877-431-03; 67877-431-01; 67877-431-05; 67877-431-33; 67877-431-38; 67877-431-32; 67877-432-03; 67877-432-01; 67877-432-05; 67877-432-33; 67877-432-38; 67877-432-32; 67877-433-03; 67877-433-01; 67877-433-05; 67877-433-33; 67877-433-38; 67877-433-32; 67877-434-03; 67877-434-01; 67877-434-05; 67877-434-33; 67877-434-38; 67877-435-03; 67877-435-01; 67877-435-05; 67877-435-33; 67877-435-38; 67877-430-03; 67877-430-01; 67877-430-05; 67877-430-33; 67877-430-38; 67877-430-32 | Superpotent drug | Ascend Laboratories, LLC / 2,256 bottles | Class II | Ongoing |
| D-0304-2026 | 08-28-2025 | Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil | Green Lumber Holdings, LLC / N/A | Class I | Ongoing |
| D-0672-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 11,909 bottles | Class III | Ongoing |
| D-0670-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 11,895 bottles | Class III | Ongoing |
| D-0669-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 3,384 bottles | Class III | Ongoing |
| D-0673-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 11,928 bottles | Class III | Ongoing |
| D-0671-2025 | 08-28-2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01 Package NDCs: 70010-029-01; 70010-030-01; 70010-031-01; 70010-032-01; 70010-033-01; 70010-034-01 | Failed Impurities/Degradation Specifications: | Granules Pharmaceuticals Inc. / 9,917 bottles | Class III | Ongoing |
| D-0650-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11) | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 873 cartons | Class II | Ongoing |
| D-0649-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11) | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 1,757 cartons | Class II | Ongoing |
| D-0648-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11) | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 1,062 cartons | 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-0647-2025 | 08-27-2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Amerisource Health Services LLC / 2,708 cartons | 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-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-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-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-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-0176-2026 | 08-27-2025 | San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 15,465 cartridges | Class II | Ongoing |
| D-0166-2026 | 08-27-2025 | GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, 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 / 115,994 containers | Class II | Ongoing |
| 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-0168-2026 | 08-27-2025 | KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 15,267 cartridges | 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-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-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-0164-2026 | 08-27-2025 | DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | DermaRite Industries, LLC / 2,673 tubes | Class II | Ongoing |
| D-0167-2026 | 08-27-2025 | Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, 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 / 576 containers | Class II | Ongoing |
| D-0623-2025 | 08-27-2025 | Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton). Package NDCs: 70710-1377-1; 70710-1377-2 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. | Zydus Pharmaceuticals (USA) Inc / 270,125 Vials | Class II | Ongoing |
| D-0629-2025 | 08-27-2025 | Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01 | cGMP violations | Atlantic Management Resources Ltd. / 72 containers | Class II | Ongoing |
| D-0655-2025 | 08-27-2025 | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19. Package NDCs: 29300-413-05; 29300-413-10; 29300-413-01; 29300-413-19; 29300-414-01; 29300-414-10; 29300-415-01; 29300-415-05; 29300-415-10; 29300-415-19 | Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). | Unichem Pharmaceuticals USA Inc. / 230 90-count bottles | Class I | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
