Total records
16,790
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Total records
16,790
Most recent report
September 24, 2025
Last updated
September 30, 2025
Sorted by most recent report date.
Recall # | Product | Firm | Status | Classification | Report date |
---|---|---|---|---|---|
D-0639-2024 | Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA. | Zeco LLC | Ongoing | Class II | Aug 28, 2024 |
D-0640-2024 | HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210 | Zeco LLC | Ongoing | Class II | Aug 28, 2024 |
D-0641-2024 | Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21. | Aurobindo Pharma USA Inc | Ongoing | Class I | Aug 28, 2024 |
D-0632-2024 | 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]. | FDC Limited | Ongoing | Class II | Aug 21, 2024 |
D-0633-2024 | Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01 | Taro Pharmaceuticals U.S.A., Inc. | Completed | Class III | Aug 21, 2024 |
D-0631-2024 | Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2 | A-S Medication Solutions LLC | Terminated | Class I | Aug 14, 2024 |
D-0628-2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26. | Novel Laboratories, Inc. d.b.a Lupin Somerset | Terminated | Class III | Aug 14, 2024 |
D-0627-2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India | Granules Consumer Health Inc. | Completed | Class III | Aug 14, 2024 |
D-0634-2024 | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05 | Granules Pharmaceuticals Inc. | Terminated | Class II | Aug 14, 2024 |
D-0630-2024 | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064 | EMPOWER CLINIC SERVICES LLC | Terminated | Class II | Aug 14, 2024 |
D-0626-2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles. | MAIN PRODUCTS INC | Ongoing | Class I | Aug 14, 2024 |
D-0629-2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1 | Amneal Pharmaceuticals, LLC | Ongoing | Class III | Aug 14, 2024 |
D-0621-2024 | Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Aug 7, 2024 |
D-0619-2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories. | Amerisource Health Services LLC | Ongoing | Class I | Aug 7, 2024 |
D-0624-2024 | Progesterone Injection, USP, 500 mg 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. | Eugia US LLC | Ongoing | Class II | Aug 7, 2024 |
D-0620-2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles. | SoloVital | Ongoing | Class I | Aug 7, 2024 |
D-0623-2024 | Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India. | FDC Limited | Ongoing | Class II | Aug 7, 2024 |
D-0617-2024 | Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 | Zydus Pharmaceuticals (USA) Inc | Terminated | Class II | Jul 31, 2024 |
D-0618-2024 | Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6. | Washington Homeopathic Products, Inc. | Terminated | Class III | Jul 31, 2024 |
D-0613-2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2 | GLOBAL WIDGET LLC | Ongoing | Class III | Jul 31, 2024 |
D-0616-2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7 | GLOBAL WIDGET LLC | Ongoing | Class III | Jul 31, 2024 |
D-0614-2024 | Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5 | GLOBAL WIDGET LLC | Ongoing | Class III | Jul 31, 2024 |
D-0615-2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0 | GLOBAL WIDGET LLC | Ongoing | Class III | Jul 31, 2024 |
D-0600-2024 | Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01. | Zydus Pharmaceuticals (USA) Inc | Terminated | Class II | Jul 24, 2024 |
D-0601-2024 | Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02. | Teva Pharmaceuticals USA, Inc | Ongoing | Class II | Jul 24, 2024 |