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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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 | Terminated |
| 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 | 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 | Terminated |
| 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-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-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-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-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-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-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-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-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-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. | 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 |
| D-0008-2025 | 09-18-2024 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia. | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine. | 123Herbals / unknown | Class I | Ongoing |
| D-0012-2025 | 09-17-2024 | Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87. Package NDCs: 69452-252-87 | Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. | Bionpharma Inc. / 1,980 bottles | Class I | Terminated |
| D-0665-2024 | 09-16-2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042 | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. / 763,426 tubes | Class II | Ongoing |
| D-0664-2024 | 09-16-2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043, | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. / 2,473,563 tubes | Class II | Ongoing |
| D-0013-2025 | 09-11-2024 | 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 Package NDCs: 0536-1271-80 | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000. | Zhejiang Jingwei Pharmaceutical Co., Ltd. / 295,164 tubes | Class II | Ongoing |
| D-0116-2025 | 09-11-2024 | Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04 Package NDCs: 18657-117-01; 18657-117-02; 18657-117-04; 1000008319; 1000008206; 1000008205 | cGMP Deviations: Temperature excursion | Mckesson Medical-Surgical Inc. Corporate Office / 5 cartons/20 units each carton | Class II | Terminated |
| D-0661-2024 | 09-11-2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06 Package NDCs: 24208-730-06 | Temperature abuse: Products exposed to improper temperature above drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 27 bottles | Class II | Terminated |
| D-0663-2024 | 09-05-2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1. | Lack of Assurance of Sterility | Empower Pharmacy / 450 | Class II | Terminated |
| D-0662-2024 | 09-03-2024 | 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 Package NDCs: 67226-2232-6 | Microbial Contamination of Non-Sterile Product | Vivier Pharma, Inc. / 3476 units | Class II | Ongoing |
| D-0668-2024 | 09-03-2024 | 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. Package NDCs: 67877-426-12; 67877-426-05; 67877-426-33; 67877-426-38; 67877-427-12; 67877-427-05; 67877-427-33; 67877-427-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 117,493 bottles | Class II | Ongoing |
| D-0660-2024 | 08-30-2024 | Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22. Package NDCs: 68462-180-22 | Subpotent Drug | Glenmark Pharmaceuticals Inc., USA / 2,031,480 ointments | Class II | Completed |
| D-0657-2024 | 08-28-2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4 | Microbial contamination of non-sterile Products - | PREQUEL SKIN / 30,946 tubes | Class II | Ongoing |
| D-0659-2024 | 08-24-2024 | AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01 Package NDCs: 72888-047-01; 72888-048-01 | Discoloration | Rubicon Research Private Limited / 3,984 bottles | Class III | Ongoing |
| D-0651-2024 | 08-22-2024 | Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01 | Lack of Assurance of Sterility | ProRx LLC / 37 vials | Class II | Ongoing |
| D-0650-2024 | 08-22-2024 | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01 | Lack of Assurance of Sterility | ProRx LLC / 2,490 vials | Class II | Ongoing |
| D-0653-2024 | 08-22-2024 | SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04 | Lack of Assurance of Sterility | ProRx LLC / 1,960 vials | Class II | Ongoing |
| D-0652-2024 | 08-22-2024 | SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01 | Lack of Assurance of Sterility | ProRx LLC / 8,396 vials | Class II | Ongoing |
| D-0656-2024 | 08-22-2024 | TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02 | Lack of Assurance of Sterility | ProRx LLC / 1,732 vials | Class II | Ongoing |
| D-0654-2024 | 08-22-2024 | Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02 | Lack of Assurance of Sterility | ProRx LLC / 500 vials | Class II | Ongoing |
| D-0655-2024 | 08-22-2024 | TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01 | Lack of Assurance of Sterility | ProRx LLC / 1,489 vials | Class II | Ongoing |
| D-0648-2024 | 08-21-2024 | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08 | Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. | Lupin Pharmaceuticals Inc. / 4554 bottles | Class II | Terminated |
| D-0658-2024 | 08-20-2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1 | LABELING: LABEL MIX-UP. | Elevate Oral Care / | Class III | Terminated |
| D-0113-2025 | 08-15-2024 | Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3 | Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection). | Biocompatibles UK, Ltd. / 432 administration packs | Class III | Terminated |
| D-0636-2024 | 08-15-2024 | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226. | Lack of Assurance of Sterility | Fagron Compounding Services / | Class II | Ongoing |
| D-0642-2024 | 08-12-2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: patients are 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 / 176,784 bottles | Class II | Ongoing |
| D-0041-2025 | 08-09-2024 | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles). | Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. | Direct Rx / 1410 bottles | Class II | Ongoing |
| D-0647-2024 | 08-08-2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03. | Failed Impurities/Degradation Specifications - at 18-month Stability testing | Preferred Pharmaceuticals, Inc. / 266 bottles | Class II | Ongoing |
| D-0637-2024 | 08-08-2024 | Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30 Package NDCs: 0591-2924-18; 0591-2925-32; 0591-2925-30; 0591-2926-25; 0591-2926-30 | Superpotent Drug | Teva Pharmaceuticals USA, Inc / 7,080 unit dose packets | Class II | Ongoing |
| D-0633-2024 | 08-07-2024 | 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 | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 96 vials | Class III | Completed |
| D-0644-2024 | 08-06-2024 | IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle. 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 impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. | Dr. Reddy's Laboratories, Inc. / 103,298 bottles | Class II | Ongoing |
| D-0645-2024 | 08-06-2024 | IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle. 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 impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. | Dr. Reddy's Laboratories, Inc. / 31,802 bottles | Class II | Ongoing |
| D-0646-2024 | 08-06-2024 | IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle. 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 impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. | Dr. Reddy's Laboratories, Inc. / 14940 bottles | Class II | Ongoing |
| D-0640-2024 | 08-05-2024 | 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 | CGMP Deviations: sterile water not used for production | Zeco LLC / | Class II | Completed |
| D-0639-2024 | 08-05-2024 | 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. | CGMP Deviations: sterile water not used for production | Zeco LLC / 604 | Class II | Completed |
| D-0630-2024 | 08-02-2024 | 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 | Lack of Assurance of Sterility | EMPOWER CLINIC SERVICES LLC / 2,797 | Class II | Terminated |
| D-0629-2024 | 08-01-2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1 | Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle. | Amneal Pharmaceuticals, LLC / 12,624 bottles | Class III | Completed |
| D-0649-2024 | 08-01-2024 | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04 Package NDCs: 0338-0431-03; 0338-0433-04; 0338-0424-18; 0338-0428-12 | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Baxter Healthcare Corporation / 44,208 containers | Class I | Ongoing |
| D-0643-2024 | 07-31-2024 | Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Package NDCs: 68462-325-60; 68462-325-90; 68462-325-01; 68462-325-05; 68462-325-10 | Failed Dissolution Specifications: below specification results | Glenmark Pharmaceuticals Inc., USA / 2404 bottles | Class II | Ongoing |
| D-0634-2024 | 07-31-2024 | 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 Package NDCs: 70010-227-01; 70010-227-05; 70010-228-01; 70010-228-05 | Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets | Granules Pharmaceuticals Inc. / 11,808 500-count Bottles | Class II | Terminated |
| D-0624-2024 | 07-26-2024 | 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. Package NDCs: 55150-306-10 | Presence of Particulate Matter: Complaint received of a glass particle in the vial. | Eugia US LLC / 17136 vials | Class II | Ongoing |
| D-0638-2024 | 07-24-2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09. Package NDCs: 0264-7800-09 | Presence of Particulate Matter | B. Braun Medical Inc / 63,444 containers | Class I | Ongoing |
| D-0623-2024 | 07-23-2024 | 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. Package NDCs: 69315-308-02; 69315-308-05; 69315-308-10 | 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 / 66,528 bottles | Class II | Ongoing |
| D-0621-2024 | 07-22-2024 | 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. Package NDCs: 68462-626-52 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 14,004 cartons | Class II | Ongoing |
| D-0626-2024 | 07-18-2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles. | Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. | MAIN PRODUCTS INC / 57, 340 bottles | Class I | Ongoing |
| D-0627-2024 | 07-18-2024 | 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 | Label mix-up: Carton incorrectly labeled. | Granules Consumer Health Inc. / 21,192 Bottles | Class III | Terminated |
| D-0632-2024 | 07-18-2024 | 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; yellow colored spike from cap lodged in the nozzle | FDC Limited / 362,544 bottles | Class II | Ongoing |
| D-0620-2024 | 07-12-2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles. | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. | SoloVital / 1,331 bottles | Class I | Ongoing |
| D-0004-2025 | 07-12-2024 | Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199 | Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil. | Supercore Products Group Inc. / 615 | Class I | Ongoing |
| D-0003-2025 | 07-12-2024 | Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A. | Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil. | Supercore Products Group Inc. / 729 | Class I | Ongoing |
| D-0641-2024 | 07-11-2024 | 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. Package NDCs: 58602-882-21; 58602-882-38 | Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. | Aurobindo Pharma USA Inc / 240 bottles | Class I | Ongoing |
| D-0622-2024 | 07-10-2024 | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02. Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg. | Endo Pharmaceuticals, Inc. / 8,139 cartons | Class I | Terminated |
| D-0597-2024 | 07-09-2024 | Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88. Package NDCs: 57664-231-88; 57664-231-18; 57664-232-88; 57664-232-18; 57664-233-88; 57664-233-18 | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 5752 bottles | Class II | Terminated |
| D-0635-2024 | 07-08-2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01 Package NDCs: 0143-9386-01; 0143-9386-10 | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) | Hikma Pharmaceuticals USA Inc. / 31,400 bags | Class I | Ongoing |
| D-0594-2024 | 07-03-2024 | Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2 | Subpotent Drug: reduced efficacy for epinephrine | TAILSTORM HEALTH INC / 12,525 10 mL vials | Class II | Ongoing |
| D-0582-2024 | 07-02-2024 | Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40. | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. | SUN PHARMACEUTICAL INDUSTRIES INC / 2088 vials | Class II | Ongoing |
| D-0628-2024 | 07-02-2024 | 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. Package NDCs: 0093-3560-19; 0093-3560-26; 0093-9044-19; 0093-9043-19 | Defective container: potential for non-sealed pouches which can lead to product leakage. | Novel Laboratories, Inc. d.b.a Lupin Somerset / 13,200 cartons | Class III | Terminated |
| D-0596-2024 | 07-02-2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box). | Cross contamination with other products | Zydus Pharmaceuticals (USA) Inc / n/a | Class III | Completed |
| D-0593-2024 | 07-02-2024 | Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5. Package NDCs: 70710-1643-5; 70710-1643-7; 70710-1644-1; 70710-1644-5 | Cross contamination with other products. | Zydus Pharmaceuticals (USA) Inc / 8020 vials | Class III | Ongoing |
