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-0099-2025 | 11-14-2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Amerisource Health Services LLC / 37,916 bottles | Class II | Ongoing |
| D-0100-2025 | 11-14-2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Amerisource Health Services LLC / 23,490 bottles | Class II | Ongoing |
| D-0102-2025 | 11-14-2024 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets Package NDCs: 68382-848-94; 68382-849-94 | Labeling: Not Elsewhere Classified - Wrong NDC number | Zydus Pharmaceuticals (USA) Inc / 4404 packs | Class III | Ongoing |
| D-0166-2025 | 11-14-2024 | UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 | cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted. | MXBBB / 321 bottles | Class II | Ongoing |
| D-0205-2025 | 11-13-2024 | Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3 | CGMP Deviations: lack of adequate release testing. | Brands International Corporation / unknown | Class II | Ongoing |
| D-0058-2025 | 11-11-2024 | Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01 Package NDCs: 48433-129-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 1470 boxes | Class II | Ongoing |
| D-0081-2025 | 11-11-2024 | Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons). Package NDCs: 49230-530-01; 49230-530-10; 49230-530-25; 49230-534-01; 49230-534-10; 49230-534-25 | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. / | Class II | Ongoing |
| D-0059-2025 | 11-11-2024 | Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01 Package NDCs: 48433-106-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 791 boxes | Class II | Ongoing |
| D-0080-2025 | 11-11-2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons). Package NDCs: 49230-530-01; 49230-530-10; 49230-530-25; 49230-534-01; 49230-534-10; 49230-534-25 | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. / | Class II | Ongoing |
| D-0082-2025 | 11-11-2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons). Package NDCs: 0517-2325-01; 0517-2325-10; 0517-2340-01; 0517-2340-10; 0517-2340-25; 0517-2310-01; 0517-2310-05 | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. / | Class II | Ongoing |
| D-0056-2025 | 11-11-2024 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 7488 boxes | Class II | Ongoing |
| D-0057-2025 | 11-11-2024 | Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 3139 boxes | Class II | Ongoing |
| D-0060-2025 | 11-11-2024 | Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 587 boxes | Class II | Ongoing |
| D-0076-2025 | 11-08-2024 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent drug | ACCORD HEALTHCARE, INC. / | Class II | Ongoing |
| D-0050-2025 | 11-07-2024 | Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70 | Failed Impurity/Degradation Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Terminated |
| D-0049-2025 | 11-07-2024 | Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72 | Failed Impurity/Degradation Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Terminated |
| D-0078-2025 | 11-07-2024 | Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc / 3336 bottles | Class II | Ongoing |
| D-0079-2025 | 11-07-2024 | Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc / | Class II | Ongoing |
| D-0077-2025 | 11-07-2024 | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc / 102576 bottles | Class II | Ongoing |
| D-0051-2025 | 11-06-2024 | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1 | Lack of Sterility Assurance | Tailstorm Health INC / 27,560 Syringes | Class II | Terminated |
| D-0087-2025 | 11-06-2024 | MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0042-2025 | 11-06-2024 | Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009 | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone. | Trinity Gold Nutrition / 150 | Class II | Ongoing |
| D-0088-2025 | 11-06-2024 | boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0089-2025 | 11-06-2024 | Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0091-2025 | 11-06-2024 | Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0090-2025 | 11-06-2024 | ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0092-2025 | 11-06-2024 | Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0045-2025 | 11-05-2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61. | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 25814 tablets | Class III | Terminated |
| D-0086-2025 | 11-04-2024 | ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0083-2025 | 11-04-2024 | VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0084-2025 | 11-04-2024 | PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0085-2025 | 11-04-2024 | ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0098-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01. Package NDCs: 16714-553-01; 16714-554-01; 16714-555-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 7296 bottles | Class II | Ongoing |
| D-0075-2025 | 11-01-2024 | Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05 | cGMP Deviations | JR Watkins / 7,138 patches | Class II | Terminated |
| D-0096-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01. Package NDCs: 16714-553-01; 16714-554-01; 16714-555-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 5232 bottles | Class II | Ongoing |
| D-0097-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01. Package NDCs: 16714-553-01; 16714-554-01; 16714-555-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 4704 bottles | Class II | Ongoing |
| D-0095-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 25584 bottles | Class II | Ongoing |
| D-0094-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 12,864 bottles | Class II | Ongoing |
| D-0093-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 34848 bottles | Class II | Ongoing |
| D-0055-2025 | 10-31-2024 | Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3 Package NDCs: 68968-0205-1; 68968-0205-3; 68968-0210-1; 68968-0210-3; 68968-0215-1; 68968-0215-3; 68968-0220-1; 68968-0220-3 | Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). | Noven Pharmaceuticals Inc / 685 boxes | Class II | Ongoing |
| D-0039-2025 | 10-30-2024 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01 Package NDCs: 36000-364-01 | Labeling: Missing Label | Baxter Healthcare Corporation / 60,594 units | Class II | Ongoing |
| D-0047-2025 | 10-29-2024 | IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05 Package NDCs: 55111-682-09; 55111-682-01; 55111-682-05; 55111-683-30; 55111-683-50; 55111-683-09; 55111-683-01; 55111-683-05; 55111-684-30; 55111-684-50; 55111-684-60; 55111-684-09; 55111-684-01; 55111-684-05 | Failed Tablet/Capsule Specifications | Dr. Reddy's Laboratories, Inc. / 3416 botttles | Class III | Ongoing |
| D-0035-2025 | 10-29-2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. 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 / 155,232 bottles | Class II | Ongoing |
| D-0038-2025 | 10-29-2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 6048 pumps | Class II | Ongoing |
| D-0112-2025 | 10-25-2024 | Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37 Package NDCs: 0527-4661-37; 0527-4662-37; 0527-4663-37; 0527-4664-37; 0527-4665-37; 0527-4666-37; 0527-4667-37 | Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. | Lannett Company Inc. / 1608 bottles | Class II | Terminated |
| D-0065-2025 | 10-24-2024 | THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 Package NDCs: 71101-001-06; 71101-001-24 | cGMP Deviations | Unexo Life Sciences Private Limited / 455,536 patches | Class II | Terminated |
| D-0066-2025 | 10-24-2024 | THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1 Package NDCs: 71101-954-05 | cGMP Deviations | Unexo Life Sciences Private Limited / 279,936 patches | Class II | Terminated |
| D-0063-2025 | 10-24-2024 | ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7 | cGMP Deviations | Unexo Life Sciences Private Limited / 4,968,000 patches | Class II | Terminated |
| D-0067-2025 | 10-24-2024 | HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6 Package NDCs: 71101-947-10 | cGMP Deviations | Unexo Life Sciences Private Limited / 10,368 patches | Class II | Terminated |
| D-0062-2025 | 10-24-2024 | ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0 | cGMP Deviations | Unexo Life Sciences Private Limited / 6,848,820 patches | Class II | Terminated |
| D-0071-2025 | 10-24-2024 | CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9 | cGMP Deviations | Unexo Life Sciences Private Limited / 17,928 patches | Class II | Terminated |
| D-0064-2025 | 10-24-2024 | ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 | cGMP Deviations | Unexo Life Sciences Private Limited / 946,080 patches | Class II | Terminated |
| D-0069-2025 | 10-24-2024 | LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105 | cGMP Deviations | Unexo Life Sciences Private Limited / 363,300 patches | Class II | Terminated |
| D-0070-2025 | 10-24-2024 | JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5 | cGMP Deviations | Unexo Life Sciences Private Limited / 10,368 patches | Class II | Terminated |
| D-0068-2025 | 10-24-2024 | EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06 Package NDCs: 79903-106-06 | cGMP Deviations | Unexo Life Sciences Private Limited / 1,101,600 patches | Class II | Terminated |
| D-0072-2025 | 10-24-2024 | PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6 Package NDCs: 55758-039-01; 55758-039-06 | cGMP Deviations | Unexo Life Sciences Private Limited / 28,864 patches | Class II | Terminated |
| D-0052-2025 | 10-23-2024 | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India Package NDCs: 68180-589-09; 68180-589-10; 68180-589-01; 68180-589-02; 68180-590-09; 68180-590-10; 68180-590-01; 68180-590-02; 68180-591-09; 68180-591-10; 68180-591-02; 68180-591-01; 68180-588-01; 68180-588-02; 68180-588-09 | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. / 112,770 bottles | Class II | Terminated |
| D-0054-2025 | 10-23-2024 | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India Package NDCs: 68180-589-09; 68180-589-10; 68180-589-01; 68180-589-02; 68180-590-09; 68180-590-10; 68180-590-01; 68180-590-02; 68180-591-09; 68180-591-10; 68180-591-02; 68180-591-01; 68180-588-01; 68180-588-02; 68180-588-09 | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. / 357,414 bottles | Class II | Terminated |
| D-0053-2025 | 10-23-2024 | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India Package NDCs: 68180-589-09; 68180-589-10; 68180-589-01; 68180-589-02; 68180-590-09; 68180-590-10; 68180-590-01; 68180-590-02; 68180-591-09; 68180-591-10; 68180-591-02; 68180-591-01; 68180-588-01; 68180-588-02; 68180-588-09 | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. / 146,322 bottles | Class II | Terminated |
| D-0044-2025 | 10-23-2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90 | Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. | Cipla USA, Inc. / N/A | Class II | Ongoing |
| D-0043-2025 | 10-23-2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98 | Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. | Cipla USA, Inc. / 1,875 boxes (cipla and exlan) | Class II | Ongoing |
| D-0037-2025 | 10-22-2024 | Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. | Failed Impurities/Degradation Specification | Dr. Reddy's Laboratories, Inc. / 532 100-count bottles | Class II | Ongoing |
| D-0036-2025 | 10-22-2024 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. | Failed Impurities/Degradation Specification | Dr. Reddy's Laboratories, Inc. / 2,040 100-count bottles | Class II | Ongoing |
| D-0029-2025 | 10-21-2024 | Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24 Package NDCs: 53185-277-24 | Superpotent Drug: Stability failure for assay at 6 months test time-point. | BLI International, Inc. / 4,901 cases/24 count each case | Class II | Terminated |
| D-0103-2025 | 10-18-2024 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28 Package NDCs: 42291-901-28; 42291-902-28; 42291-903-28; 42291-904-28 | Labeling: Label Mix-Up | AvKARE / 40 bottles | Class II | Ongoing |
| D-0104-2025 | 10-18-2024 | Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28 Package NDCs: 42291-901-28; 42291-902-28; 42291-903-28; 42291-904-28 | Labeling: Label Mix-Up | AvKARE / 20 bottles | Class II | Ongoing |
| D-0046-2025 | 10-17-2024 | Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10 | Subpotent Drug | Keystone Industries / 787 pumps | Class II | Ongoing |
| D-0025-2025 | 10-15-2024 | OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06. | CGMP Deviations | Akron Pharma, Inc. / 10845 bottles | Class II | Ongoing |
| D-0048-2025 | 10-11-2024 | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05 | Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing. | Padagis US LLC / 10,872 jars | Class III | Terminated |
| D-0031-2025 | 10-10-2024 | Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. Package NDCs: 16729-440-10; 16729-440-15; 16729-440-01; 16729-441-10; 16729-441-15; 16729-441-01; 16729-442-10; 16729-442-15; 16729-442-01 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0030-2025 | 10-10-2024 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. Package NDCs: 16729-440-10; 16729-440-15; 16729-440-01; 16729-441-10; 16729-441-15; 16729-441-01; 16729-442-10; 16729-442-15; 16729-442-01 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0032-2025 | 10-10-2024 | Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. Package NDCs: 16729-440-10; 16729-440-15; 16729-440-01; 16729-441-10; 16729-441-15; 16729-441-01; 16729-442-10; 16729-442-15; 16729-442-01 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | ACCORD HEALTHCARE, INC. / N/A | Class II | Ongoing |
| D-0009-2025 | 10-10-2024 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05. 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 / 7,107 bottles | Class II | Completed |
| D-0026-2025 | 10-09-2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. Package NDCs: 43598-367-30; 43598-367-05; 43598-368-30; 43598-368-05; 43598-369-30; 43598-369-05 | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Dr. Reddy's Laboratories, Inc. / 285126 bottles | Class II | Ongoing |
| D-0028-2025 | 10-09-2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. Package NDCs: 43598-367-30; 43598-367-05; 43598-368-30; 43598-368-05; 43598-369-30; 43598-369-05 | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Dr. Reddy's Laboratories, Inc. / 10584 bottles | Class II | Ongoing |
| D-0027-2025 | 10-09-2024 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. Package NDCs: 43598-367-30; 43598-367-05; 43598-368-30; 43598-368-05; 43598-369-30; 43598-369-05 | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Dr. Reddy's Laboratories, Inc. / 35880 bottles | Class II | Ongoing |
| D-0024-2025 | 10-08-2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, | Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen. | C & A Naturistics / Unknown | Class II | Ongoing |
| D-0073-2025 | 10-08-2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01 | CGMP violations. | Neogen Corporation / 5,328 sachets | Class II | Ongoing |
| D-0074-2025 | 10-08-2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02 | CGMP violations. | Neogen Corporation / 8,328 jugs | Class II | Ongoing |
| D-0010-2025 | 10-01-2024 | Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38 Package NDCs: 16729-288-11; 16729-288-38 | Failed Impurities/Degradation Specifications. | ACCORD HEALTHCARE, INC. / 11,214 vials | Class II | Terminated |
| D-0040-2025 | 09-30-2024 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317 | Presence of Particulate Matter: Presence of glass particulates. | Staska Pharmaceuticals, Inc. / 4773 vials | Class I | Terminated |
| D-0002-2025 | 09-30-2024 | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. | Defective Container: Firm received complaints of broken tube at the seal. | Glenmark Pharmaceuticals Inc., USA / 11,568 tubes | Class III | Ongoing |
| D-0016-2025 | 09-25-2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 2756 bags | Class II | Terminated |
| D-0018-2025 | 09-25-2024 | Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 1082 bags | Class II | Terminated |
| D-0023-2025 | 09-25-2024 | Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56 | cGMP violations | Fresenius Kabi Compounding, LLC / 1008 bags | Class II | Terminated |
| D-0015-2025 | 09-25-2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 1631 bags | Class II | Terminated |
| D-0034-2025 | 09-25-2024 | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018 Package NDCs: 69676-0079-3; 69676-0077-9; 69676-0094-9; 8500157360 | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. | Denison Pharmaceuticals, LLC / 105,048 bottles | Class III | Ongoing |
| D-0017-2025 | 09-25-2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 1378 bags | Class II | Terminated |
| D-0022-2025 | 09-25-2024 | EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 753 bags | Class II | Terminated |
| D-0021-2025 | 09-25-2024 | Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59 | cGMP violations | Fresenius Kabi Compounding, LLC / 4436 bags | Class II | Terminated |
| D-0019-2025 | 09-25-2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 2151 bags | Class II | Terminated |
| D-0014-2025 | 09-25-2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58 | CGMP violations | Fresenius Kabi Compounding, LLC / 1313 bags | Class II | Terminated |
| D-0020-2025 | 09-25-2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58 | cGMP violations | Fresenius Kabi Compounding, LLC / 733 bags | Class II | Terminated |
| D-0033-2025 | 09-25-2024 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155 Package NDCs: 69676-0079-3; 69676-0077-9; 69676-0094-9; 8500157361 | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. | Denison Pharmaceuticals, LLC / 72,648 bottles | Class III | Ongoing |
| D-0001-2025 | 09-24-2024 | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01. Package NDCs: 75834-256-90; 75834-256-01; 75834-256-05; 75834-256-50; 75834-255-90; 75834-255-01; 75834-255-05; 75834-255-50; 75834-257-90; 75834-257-50; 75834-257-25; 75834-257-01; 75834-258-90; 75834-258-50; 75834-258-02; 75834-258-01 | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg. | Nivagen Pharmaceuticals Inc / 2328 bottles | Class II | Terminated |
| D-0006-2025 | 09-24-2024 | Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27. Package NDCs: 59467-700-27; 59467-700-84 | Defective Delivery System: The dip tube is clogged causing the spray not to work. | Glenmark Pharmaceuticals Inc., USA / 45,504 bottles | Class II | Ongoing |
| D-0011-2025 | 09-24-2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 2544 pumps | Class II | Ongoing |
| D-0007-2025 | 09-23-2024 | Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61 | CGMP deviations | Advanced Accelerator Applications USA, Inc. / 99 doses | Class II | Ongoing |
| D-0005-2025 | 09-19-2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2 Package NDCs: 61958-2902-2; 61958-2901-2 | Presence of Particulate Matter: Presence of glass particle. | Gilead Sciences, Inc. / 105,000 vials | Class I | Terminated |
| D-0667-2024 | 09-18-2024 | EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1 | CGMP deviations | EnviroServe Chemicals Inc. / 120 bottles | Class II | Ongoing |
