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
Sorted by most recent report date.
Back to datasets
Page 47 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0097-2024 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01. | Zydus Pharmaceuticals (USA) Inc | Completed | Class II | Nov 15, 2023 |
| D-0100-2024 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24 | Pfizer Inc. | Terminated | Class I | Nov 15, 2023 |
| D-0091-2024 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79 | MEDLINE INDUSTRIES, LP - Northfield | Terminated | Class II | Nov 15, 2023 |
| D-0093-2024 | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. | VistaPharm LLC | Terminated | Class III | Nov 15, 2023 |
| D-0086-2024 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10. | Dr. Reddy's Laboratories, Inc. | Terminated | Class II | Nov 15, 2023 |
| D-0099-2024 | V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 | Grato Holdings, Inc. | Terminated | Class III | Nov 15, 2023 |
| D-0092-2024 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Nov 15, 2023 |
| D-0095-2024 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30 | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Nov 15, 2023 |
| D-0089-2024 | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1 | Taro Pharmaceuticals Inc. | Terminated | Class III | Nov 15, 2023 |
| D-0090-2024 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10 | Amneal Pharmaceuticals of New York, LLC | Terminated | Class II | Nov 15, 2023 |
| D-0085-2024 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01 | Glenmark Pharmaceuticals Inc., USA | Terminated | Class III | Nov 8, 2023 |
| D-0075-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0074-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0073-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0079-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0082-2024 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15 | Safecor Health, LLC | Terminated | Class II | Nov 8, 2023 |
| D-0080-2024 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01 | Edenbridge Pharmaceuticals, LLC | Terminated | Class III | Nov 8, 2023 |
| D-0078-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0076-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0077-2024 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Completed | Class II | Nov 8, 2023 |
| D-0081-2024 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01 | Padagis US LLC | Ongoing | Class II | Nov 8, 2023 |
| D-0084-2024 | Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88 | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated | Class II | Nov 8, 2023 |
| D-0083-2024 | Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88 | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated | Class II | Nov 8, 2023 |
| D-0070-2024 | Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70 | Denver Solutions, LLC DBA Leiters Health | Terminated | Class III | Nov 1, 2023 |
| D-0071-2024 | VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68. | Denver Solutions, LLC DBA Leiters Health | Terminated | Class III | Nov 1, 2023 |