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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 25 of 672
| Recall # | Product | Firm | Status | Classification | Report date |
|---|---|---|---|---|---|
| D-0029-2025 | Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24 | BLI International, Inc. | Ongoing | Class II | Nov 6, 2024 |
| D-0031-2025 | 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. | ACCORD HEALTHCARE, INC. | Ongoing | Class II | Nov 6, 2024 |
| D-0018-2025 | 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 | Fresenius Kabi Compounding, LLC | Terminated | Class II | Oct 30, 2024 |
| D-0014-2025 | 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 | Fresenius Kabi Compounding, LLC | Terminated | Class II | Oct 30, 2024 |
| D-0019-2025 | 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 | Fresenius Kabi Compounding, LLC | Terminated | Class II | Oct 30, 2024 |
| D-0021-2025 | 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 | Fresenius Kabi Compounding, LLC | Terminated | Class II | Oct 30, 2024 |
| D-0020-2025 | 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 | Fresenius Kabi Compounding, LLC | Terminated | Class II | Oct 30, 2024 |
| D-0025-2025 | 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. | Akron Pharma, Inc. | Ongoing | Class II | Oct 30, 2024 |
| D-0024-2025 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, | C & A Naturistics | Ongoing | Class II | Oct 30, 2024 |
| D-0016-2025 | 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 | Fresenius Kabi Compounding, LLC | Terminated | Class II | Oct 30, 2024 |
| D-0013-2025 | First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80 | Zhejiang Jingwei Pharmaceutical Co., Ltd. | Ongoing | Class II | Oct 23, 2024 |
| D-0009-2025 | 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. | Breckenridge Pharmaceutical, Inc | Completed | Class II | Oct 23, 2024 |
| D-0010-2025 | 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 | ACCORD HEALTHCARE, INC. | Ongoing | Class II | Oct 23, 2024 |
| D-0011-2025 | 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. | VIONA PHARMACEUTICALS INC | Ongoing | Class II | Oct 23, 2024 |
| D-0008-2025 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia. | 123Herbals | Ongoing | Class I | Oct 16, 2024 |
| D-0001-2025 | 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. | Nivagen Pharmaceuticals Inc | Ongoing | Class II | Oct 9, 2024 |
| D-0003-2025 | Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A. | Supercore Products Group Inc. | Ongoing | Class I | Oct 9, 2024 |
| D-0006-2025 | 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. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class II | Oct 9, 2024 |
| D-0007-2025 | 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 | Advanced Accelerator Applications USA, Inc. | Ongoing | Class II | Oct 9, 2024 |
| D-0004-2025 | Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199 | Supercore Products Group Inc. | Ongoing | Class I | Oct 9, 2024 |
| D-0002-2025 | 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. | Glenmark Pharmaceuticals Inc., USA | Ongoing | Class III | Oct 9, 2024 |
| D-0661-2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06 | Mckesson Medical-Surgical Inc. Corporate Office | Terminated | Class II | Oct 2, 2024 |
| D-0668-2024 | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12. | Ascend Laboratories, LLC | Ongoing | Class II | Oct 2, 2024 |
| D-0667-2024 | 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 | EnviroServe Chemicals Inc. | Ongoing | Class II | Oct 2, 2024 |
| D-0662-2024 | Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R | Vivier Pharma, Inc. | Ongoing | Class II | Oct 2, 2024 |