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-0188-2025 | 12-30-2024 | Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 42,527 bottles | Class II | Ongoing |
| D-0190-2025 | 12-30-2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 244,460 bottles | Class II | Ongoing |
| D-0186-2025 | 12-27-2024 | Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 Package NDCs: 55150-306-10 | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. | Eugia US LLC / 17,300 10-mL vials | Class II | Ongoing |
| D-0204-2025 | 12-23-2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93 Package NDCs: 58151-078-93; 58151-079-93 | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc / 6,605/30 count bottles | Class II | Terminated |
| D-0203-2025 | 12-23-2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93 Package NDCs: 58151-078-93; 58151-079-93 | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc / 1,215/30 count bottles | Class II | Terminated |
| D-0210-2025 | 12-23-2024 | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. Package NDCs: 0469-0647-73; 0469-0647-11; 0469-0677-73; 0469-0677-11; 0469-0687-73; 0469-0687-11 | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Astellas Pharma US Inc. / 3,500 30-count bottles | Class I | Ongoing |
| D-0211-2025 | 12-23-2024 | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. Package NDCs: 0469-0607-73; 0469-0617-73; 0469-0617-11; 0469-0657-73; 0469-0657-11; 0469-3016-01; 0469-1230-50; 0469-1330-50 | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Astellas Pharma US Inc. / 14,340 100-count bottles | Class I | Ongoing |
| D-0206-2025 | 12-23-2024 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 | CGMP Deviations; product intended for quarantine was inadvertently distributed | First Aid Beauty Ltd / 2756 jars | Class II | Ongoing |
| D-0167-2025 | 12-20-2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03 Package NDCs: 68180-965-03; 68180-965-02; 68180-965-09; 68180-965-01; 68180-966-03; 68180-966-02; 68180-966-09; 68180-966-01; 68180-967-03; 68180-967-02; 68180-967-09; 68180-967-01; 68180-968-09; 68180-968-02; 68180-968-01; 68180-968-03; 68180-969-01; 68180-969-02; 68180-969-03; 68180-969-09; 68180-970-01; 68180-970-02; 68180-970-03; 68180-970-09; 68180-971-01; 68180-971-02; 68180-971-03; 68180-971-09; 68180-972-01; 68180-972-02; 68180-972-03; 68180-972-09; 68180-973-01; 68180-973-02; 68180-973-03; 68180-973-09; 68180-974-01; 68180-974-02; 68180-974-03; 68180-974-09; 68180-975-03; 68180-975-02; 68180-975-01; 68180-975-09; 68180-976-01; 68180-976-02; 68180-976-03; 68180-976-09 | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. | Lupin Pharmaceuticals Inc. / 480 1000-count bottles | Class II | Terminated |
| D-0223-2025 | 12-20-2024 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01 | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) | ENDO USA, Inc. / 44,397 amber glass vials | Class I | Ongoing |
| D-0174-2025 | 12-19-2024 | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. | Hikma Injectables USA Inc / | Class II | Terminated |
| D-0183-2025 | 12-19-2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20 Package NDCs: 0054-0709-25; 0054-0709-20; 0054-0710-25; 0054-0710-20 | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. | West-Ward Columbus Inc / 2591 100-count boxes | Class III | Ongoing |
| D-0173-2025 | 12-19-2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25 | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. | Hikma Injectables USA Inc / 1,800 syringes | Class II | Terminated |
| D-0175-2025 | 12-18-2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15. Package NDCs: 50268-068-15; 50268-068-02 | LABELING: LABEL MIX-UP | AvKARE / 16,677 cartons | Class III | Ongoing |
| D-0187-2025 | 12-18-2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 Package NDCs: 70010-001-01; 70010-001-10; 70010-001-03 | Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. | Granules Pharmaceuticals Inc. / 96 Bottles | Class II | Terminated |
| D-0185-2025 | 12-18-2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India Package NDCs: 55150-329-01; 55150-329-25; 55150-330-01 | CGMP Deviations | Eugia US LLC / 19872 vials | Class II | Ongoing |
| D-0176-2025 | 12-18-2024 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15 Package NDCs: 50268-678-15 | LABELING: LABEL MIX-UP | AvKARE / 0 | Class III | Ongoing |
| D-0200-2025 | 12-18-2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134 | Non-Sterility | Alcon Research LLC / 55,960 25-count boxes | Class I | Ongoing |
| D-0202-2025 | 12-17-2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11 | Failed Dissolution Specifications: | Amerisource Health Services LLC / 2,028 units (cartons of 30 individual unit doses) | Class II | Terminated |
| D-0207-2025 | 12-16-2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7 | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide | SHOPPERS- PLAZA / 172 180-count bottles | Class I | Ongoing |
| D-0169-2025 | 12-16-2024 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 Package NDCs: 70069-716-01 | Failed Impurities/Degradation Specifications | SOMERSET THERAPEUTICS LLC / 5,870 bottles | Class III | Terminated |
| D-0182-2025 | 12-16-2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 Package NDCs: 69315-308-02; 69315-308-05; 69315-308-10 | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle | FDC Limited / 136,181 bottles | Class II | Ongoing |
| D-0184-2025 | 12-13-2024 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21 Package NDCs: 60687-423-11; 60687-423-21 | Presence of Foreign Tablets/Capsules | Amerisource Health Services LLC / 5,178 cartons | Class II | Ongoing |
| D-0130-2025 | 12-12-2024 | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60 Package NDCs: 67877-475-60; 67877-474-60; 67877-624-60; 67877-624-31 | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC / 10,444 bottles | Class II | Ongoing |
| D-0196-2025 | 12-12-2024 | Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02 | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 1232 bottles | Class III | Ongoing |
| D-0177-2025 | 12-12-2024 | Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia. | Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine | Buy-Herbal / 26 bottles | Class I | Ongoing |
| D-0198-2025 | 12-12-2024 | Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 456 bottles | Class III | Ongoing |
| D-0197-2025 | 12-12-2024 | Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 7198 bottles | Class III | Ongoing |
| D-0170-2025 | 12-12-2024 | FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles | Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone. | GNMart LLC / 374 bottles | Class I | Ongoing |
| D-0194-2025 | 12-12-2024 | Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 . | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 6429 bottles | Class III | Ongoing |
| D-0195-2025 | 12-12-2024 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 14825 bottles | Class III | Ongoing |
| D-0199-2025 | 12-12-2024 | Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 324 bottles | Class III | Ongoing |
| D-0193-2025 | 12-12-2024 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 768 bottles | Class III | Ongoing |
| D-0129-2025 | 12-12-2024 | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60 Package NDCs: 67877-475-60; 67877-474-60; 67877-624-60; 67877-624-31 | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC / 1971 bottles | Class II | Ongoing |
| D-0160-2025 | 12-11-2024 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01 Package NDCs: 68462-861-01; 68462-861-10; 68462-862-01; 68462-862-10; 68462-863-01; 68462-863-10; 68462-864-01; 68462-864-10; 68462-865-01; 68462-865-10 | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0159-2025 | 12-11-2024 | chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 Package NDCs: 68462-861-01; 68462-861-10; 68462-862-01; 68462-862-10; 68462-863-01; 68462-863-10; 68462-864-01; 68462-864-10; 68462-865-01; 68462-865-10 | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 3,888 | Class II | Ongoing |
| D-0171-2025 | 12-10-2024 | Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 23304 packs | Class II | Ongoing |
| D-0172-2025 | 12-10-2024 | Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 2760 packs | Class II | Ongoing |
| D-0153-2025 | 12-10-2024 | PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01 | Lack of Sterility Assurance | Regenerative Processing Plant, LLC / 59275 | Class II | Terminated |
| D-0152-2025 | 12-10-2024 | LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01 | Lack of Sterility Assurance | Regenerative Processing Plant, LLC / 170812 bottles | Class II | Terminated |
| D-0149-2025 | 12-06-2024 | Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30 Package NDCs: 59651-137-30; 59651-137-90; 59651-138-30; 59651-138-90; 59651-139-30; 59651-139-90; 59651-140-30; 59651-140-90 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. | Aurobindo Pharma USA Inc / | Class II | Ongoing |
| D-0156-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 13,678 bottles | Class II | Ongoing |
| D-0157-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 20,734 30-count bottles | Class II | Ongoing |
| D-0155-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 21,262 bottles | Class II | Ongoing |
| D-0158-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 1,815 bottles | Class II | Ongoing |
| D-0161-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc / 163,883 bottles | Class II | Ongoing |
| D-0162-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc / 76,968 bottles | Class II | Ongoing |
| D-0114-2025 | 12-05-2024 | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. | FDC Limited / 5184 bottles | Class II | Ongoing |
| D-0168-2025 | 12-04-2024 | Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15. | Failed Dissolution Specifications | AvKARE / 1016 50-count cartons | Class II | Ongoing |
| D-0163-2025 | 12-04-2024 | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 | CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit | PD-Rx Pharmaceuticals, Inc. / 70, 90-count bottles | Class II | Terminated |
| D-0165-2025 | 12-02-2024 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. | RemedyRepack Inc. / a) 1,564 cards, b) 799 bottles | Class II | Ongoing |
| D-0108-2025 | 11-27-2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30 | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE / 50,304 bottles | Class II | Ongoing |
| D-0109-2025 | 11-27-2024 | Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30 | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE / 2,396 bottles | Class II | Ongoing |
| D-0110-2025 | 11-27-2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30 | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE / 2,796 bottles | Class II | Ongoing |
| D-0164-2025 | 11-26-2024 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40 Package NDCs: 69945-092-20; 69945-092-40 | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product | Curium US, LLC / 5,160 vials (172 kits 30 vials/kit) | Class II | Terminated |
| D-0154-2025 | 11-25-2024 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07. Package NDCs: 33342-067-07; 33342-067-44; 33342-067-12; 33342-067-11; 33342-068-07; 33342-068-44; 33342-068-12; 33342-068-11; 33342-069-07; 33342-069-44; 33342-069-12; 33342-069-11; 33342-070-07; 33342-070-15; 33342-070-12; 33342-070-44; 33342-070-11; 33342-071-07; 33342-071-15; 33342-071-12; 33342-071-44; 33342-071-11; 33342-072-07; 33342-072-15; 33342-072-12; 33342-072-44; 33342-072-11 | Failed Impurities/Degradation Specifications | Macleods Pharmaceuticals Ltd / 15,744 30-count bottles | Class II | Ongoing |
| D-0151-2025 | 11-22-2024 | VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10 Package NDCs: 52925-512-10; 52925-512-25 | CGMP deviations: out of specifications for assay | Apothecus Pharmaceutical Corp. / 33,659 retail boxes in US | Class II | Ongoing |
| D-0117-2025 | 11-22-2024 | Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04. Package NDCs: 43598-096-30; 43598-096-04; 43598-096-05 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 7,233 bottles | Class III | Ongoing |
| D-0150-2025 | 11-22-2024 | Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05 Package NDCs: 81284-411-00; 81284-411-05; 81284-411-10 | Discoloration | Provepharm Inc. / 2160 packs/5 ampules per pack = 10,800 ampules | Class II | Ongoing |
| D-0111-2025 | 11-22-2024 | 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com. | CGMP Deviations: Inconsistency in the water systems. | Generitech Corporation / 77.5lbs | Class II | Ongoing |
| D-0191-2025 | 11-22-2024 | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05. | Failed Stability Specifications | Jubilant Draximage Inc., dba Jubilant Radiopharma / 5209 kits | Class II | Ongoing |
| D-0107-2025 | 11-19-2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Rising Pharma Holding, Inc. / 233,003 bottles | Class II | Ongoing |
| D-0131-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20 Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 2,835 cartons | Class II | Ongoing |
| D-0136-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20 Package NDCs: 42292-038-01; 42292-038-20; 42292-039-01; 42292-039-20; 42292-041-01; 42292-041-20; 42292-040-01; 42292-040-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 205 cartons | Class II | Ongoing |
| D-0133-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20 Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 1,664 cartons | Class II | Ongoing |
| D-0135-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20 Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 690 cartons | Class II | Ongoing |
| D-0134-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20 Package NDCs: 42292-038-01; 42292-038-20; 42292-039-01; 42292-039-20; 42292-041-01; 42292-041-20; 42292-040-01; 42292-040-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 1,133 cartons | Class II | Ongoing |
| D-0132-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-20 Package NDCs: 42292-038-01; 42292-038-20; 42292-039-01; 42292-039-20; 42292-041-01; 42292-041-20; 42292-040-01; 42292-040-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 988 cartons | Class II | Ongoing |
| D-0106-2025 | 11-19-2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Rising Pharma Holding, Inc. / 122,925 bottles | Class II | Ongoing |
| D-0105-2025 | 11-19-2024 | Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Rising Pharma Holding, Inc. / 209,376 bottles | Class II | Ongoing |
| D-0179-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-306-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 8,029 cartons | Class I | Ongoing |
| D-0181-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-309-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 22,513 cartons | Class I | Ongoing |
| D-0178-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-310-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 9,816 cartons | Class I | Ongoing |
| D-0180-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-307-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 72,973 cartons | Class I | Ongoing |
| D-0120-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 9,828 bottles | Class II | Ongoing |
| D-0126-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 43,765 bottles | Class II | Ongoing |
| D-0125-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 63,077 bottles | Class II | Ongoing |
| D-0122-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 55,032 bottles | Class II | Ongoing |
| D-0123-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 34,845 bottes | Class II | Ongoing |
| D-0119-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 118,324 bottles | Class II | Ongoing |
| D-0124-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 42,331 bottles | Class II | Ongoing |
| D-0121-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 19, 549 bottles | Class II | Ongoing |
| D-0128-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 35,883 bottles | Class II | Ongoing |
| D-0127-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 65,169 | Class II | Ongoing |
| D-0118-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 92,512 bottles | Class II | Ongoing |
| D-0061-2025 | 11-15-2024 | Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90. Package NDCs: 68645-609-90; 68645-610-90; 68645-611-90; 68645-608-90; 68645-612-90; 68645-613-90 | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. | Evaric Pharmaceuticals Inc. / 222, 600 bottles | Class II | Terminated |
| D-0144-2025 | 11-14-2024 | Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0138-2025 | 11-14-2024 | M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0147-2025 | 11-14-2024 | Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0145-2025 | 11-14-2024 | safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only. Package NDCs: 67239-0219-1 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0141-2025 | 11-14-2024 | Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3. Package NDCs: 50227-1002-3 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0137-2025 | 11-14-2024 | Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30. Package NDCs: 68400-352-30 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0146-2025 | 11-14-2024 | Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0139-2025 | 11-14-2024 | Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0142-2025 | 11-14-2024 | Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30. Package NDCs: 69634-021-30 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0115-2025 | 11-14-2024 | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81 Package NDCs: 63981-795-81 | CGMP Deviations: Released product should have been rejected. | LNK International, Inc. / 288 cases x 30 8,640 boxes | Class II | Terminated |
| D-0143-2025 | 11-14-2024 | Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0140-2025 | 11-14-2024 | Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0148-2025 | 11-14-2024 | Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only, | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Terminated |
| D-0101-2025 | 11-14-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Amerisource Health Services LLC / 8,561 bottles | Class II | Ongoing |
