Total records
16,790
Drug Enforcements
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Most recent report
September 24, 2025
Last updated
September 30, 2025
Drug Enforcement Records
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Page 18 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0221-2025 | Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing | Class II | Feb 12, 2025 |
| D-0223-2025 | 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 | Endo USA, Inc. | Ongoing | Class I | Feb 12, 2025 |
| D-0214-2025 | 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. | FDC Limited | Ongoing | Class II | Feb 12, 2025 |
| D-0209-2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 | The W.S. Badger Company, Inc. | Terminated | Class III | Feb 5, 2025 |
| D-0211-2025 | 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. | Astellas Pharma US Inc. | Ongoing | Class I | Feb 5, 2025 |
| D-0212-2025 | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing | Class II | Feb 5, 2025 |
| D-0210-2025 | 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. | Astellas Pharma US Inc. | Ongoing | Class I | Feb 5, 2025 |
| D-0208-2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. | Appco Pharma LLC | Ongoing | Class III | Jan 29, 2025 |
| D-0207-2025 | 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 | SHOPPERS- PLAZA | Ongoing | Class I | Jan 29, 2025 |
| D-0206-2025 | 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 | First Aid Beauty Ltd | Ongoing | Class II | Jan 29, 2025 |
| D-0205-2025 | 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 | Brands International Corporation | Ongoing | Class II | Jan 29, 2025 |
| D-0201-2025 | 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 60687-423-11 | Amerisource Health Services LLC | Ongoing | Class II | Jan 22, 2025 |
| D-0202-2025 | 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 | Amerisource Health Services LLC | Ongoing | Class II | Jan 22, 2025 |
| D-0197-2025 | 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. | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0193-2025 | 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. | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0200-2025 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134 | Alcon Research LLC | Ongoing | Class I | Jan 22, 2025 |
| D-0194-2025 | 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 . | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0204-2025 | 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 | Viatris Inc | Ongoing | Class II | Jan 22, 2025 |
| D-0196-2025 | 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 | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0199-2025 | 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. | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0195-2025 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01. | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0203-2025 | 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 | Viatris Inc | Ongoing | Class II | Jan 22, 2025 |
| D-0198-2025 | 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. | Akron Pharma, Inc. | Ongoing | Class III | Jan 22, 2025 |
| D-0183-2025 | 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 | West-Ward Columbus Inc | Ongoing | Class III | Jan 15, 2025 |
| D-0187-2025 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 | Granules Pharmaceuticals Inc. | Terminated | Class II | Jan 15, 2025 |