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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0594-2025 | 08-20-2025 | Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61 Package NDCs: 0904-7305-61; 0904-7306-61; 0904-7307-61; 0904-7308-61 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 26,628 cartons | Class II | Ongoing |
| D-0595-2025 | 08-12-2025 | Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04 Package NDCs: 72578-102-04 | Discoloration | VIONA PHARMACEUTICALS INC / 3960 bottles | Class II | Ongoing |
| D-0583-2025 | 08-08-2025 | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01 Package NDCs: 68462-380-01; 68462-380-05; 68462-356-01; 68462-356-05 | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria. | Glenmark Pharmaceuticals Inc., USA / 22,656 bottles | Class II | Ongoing |
| D-0578-2025 | 08-07-2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Glenmark Pharmaceuticals Inc., USA / 6,432 bottles | Class II | Ongoing |
| D-0577-2025 | 08-07-2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Glenmark Pharmaceuticals Inc., USA / 44,328 bottles | Class II | Ongoing |
| D-0579-2025 | 08-07-2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Glenmark Pharmaceuticals Inc., USA / 4,800 bottles | Class II | Ongoing |
| D-0587-2025 | 08-06-2025 | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | Glenmark Pharmaceuticals Inc., USA / 17, 496 bottles | Class II | Ongoing |
| D-0588-2025 | 08-06-2025 | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | Glenmark Pharmaceuticals Inc., USA / 14,976 bottles | Class II | Ongoing |
| D-0582-2025 | 08-06-2025 | Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10 Package NDCs: 69367-354-10; 69367-354-01; 69367-355-10; 69367-355-01 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Westminster Pharmaceuticals LLC / 4,456 1000-count bottles | Class II | Ongoing |
| D-0581-2025 | 08-06-2025 | Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10 Package NDCs: 69367-354-10; 69367-354-01; 69367-355-10; 69367-355-01 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Westminster Pharmaceuticals LLC / 16,672 1000-count bottles | Class II | Ongoing |
| D-0592-2025 | 08-05-2025 | Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2 | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton | Haleon US Holdings LLC / 46,692 tubes | Class III | Ongoing |
| D-0574-2025 | 08-05-2025 | Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01 Package NDCs: 53489-143-01; 53489-143-05; 53489-143-10; 53489-328-07; 53489-328-02; 53489-328-06; 53489-328-01; 53489-328-03; 53489-328-05; 53489-328-10; 53489-329-07; 53489-329-02; 53489-329-06; 53489-329-01; 53489-329-03; 53489-329-05; 53489-329-10 | Presence of foreign substance: identified as aluminum. | SUN PHARMACEUTICAL INDUSTRIES INC / 11,328 bottles | Class II | Ongoing |
| D-0590-2025 | 08-04-2025 | Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10. Package NDCs: 0409-4933-11; 0409-4933-01; 0409-4933-05; 0409-4933-10 | Lack of Assurance of Sterility. | PFIZER INC / 49,620 vials | Class II | Ongoing |
| D-0585-2025 | 08-04-2025 | Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00. Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | B BRAUN MEDICAL INC / 74,088 containers | Class II | Ongoing |
| D-0586-2025 | 08-04-2025 | 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00. Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | B BRAUN MEDICAL INC / 23,100 containers | Class II | Ongoing |
| D-0591-2025 | 08-04-2025 | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14. Package NDCs: 0409-4916-24; 0409-4916-14; 0409-6637-24; 0409-6637-14; 00409-6637-14 | Lack of Assurance of Sterility. | PFIZER INC / 15,750 vials | Class II | Ongoing |
| D-0572-2025 | 07-30-2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55 Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 4 units | Class II | Ongoing |
| D-0573-2025 | 07-30-2025 | RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 3 units | Class II | Ongoing |
| D-0571-2025 | 07-30-2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55. Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 6 units | Class II | Ongoing |
| D-0575-2025 | 07-29-2025 | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent drug | Pfizer / 29, 004 bottles | Class II | Ongoing |
| D-0580-2025 | 07-25-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10 Package NDCs: 82009-029-05; 82009-030-10; 82009-032-10; 82009-031-30; 82009-031-90 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 1,856 bottles | Class II | Ongoing |
| D-0566-2025 | 07-25-2025 | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31 Package NDCs: 62332-637-31; 62332-637-91; 62332-638-31; 62332-638-91; 62332-645-31; 62332-645-91; 62332-639-31; 62332-639-91; 62332-640-31; 62332-640-91; 2305015142 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Alembic Pharmaceuticals Limited / 9,492 bottles | Class II | Ongoing |
| D-0593-2025 | 07-24-2025 | Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60. Package NDCs: 69097-142-60 | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. | Cipla USA, Inc. / 20352 packs (1x 200 MD) | Class III | Ongoing |
| D-0589-2025 | 07-22-2025 | BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01 | Lack of Assurance of Sterility. | Taizhou Kangping Medical Science And Technology Co., Ltd. / 3.85 million Cartons | Class II | Ongoing |
| D-0551-2025 | 07-22-2025 | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10 | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds | Hikma Pharmaceuticals USA Inc. / 382,775 1mL vials | Class II | Ongoing |
| D-0584-2025 | 07-21-2025 | Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label) Package NDCs: 0006-0005-10; 0006-0005-30; 0006-0005-13; 0006-0033-10; 0006-0033-30; 0006-0033-13; 0006-0325-10; 0006-0325-30; 0006-0325-13; 0006-0335-10; 0006-0335-30; 0006-0335-13 | Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep. | Merck & Co. Inc / 51,320 cartons | Class II | Ongoing |
| D-0576-2025 | 07-21-2025 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30 Package NDCs: 67877-499-30; 67877-499-90; 67877-500-30; 67877-500-90; 67877-501-30; 67877-501-90; 67877-502-30; 67877-502-90 | Failed Dissolution Specifications: low dissolution results | Ascend Laboratories, LLC / 8,568 bottles | Class II | Ongoing |
| D-0555-2025 | 07-18-2025 | Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 170 vials | Class II | Ongoing |
| D-0560-2025 | 07-18-2025 | Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 155 vials | Class II | Ongoing |
| D-0557-2025 | 07-18-2025 | Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 139 vials | Class II | Ongoing |
| D-0554-2025 | 07-18-2025 | Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 236 vials | Class II | Ongoing |
| D-0565-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 158 vials | Class II | Ongoing |
| D-0558-2025 | 07-18-2025 | Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 146 vials | Class II | Ongoing |
| D-0559-2025 | 07-18-2025 | Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 143 vials | Class II | Ongoing |
| D-0553-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 290 vials | Class II | Ongoing |
| D-0564-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 176 vials | Class II | Ongoing |
| D-0563-2025 | 07-18-2025 | Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 190 vials | Class II | Ongoing |
| D-0561-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 221 vials | Class II | Ongoing |
| D-0556-2025 | 07-18-2025 | Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 160 vials | Class II | Ongoing |
| D-0562-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 194 vials | Class II | Ongoing |
| D-0552-2025 | 07-15-2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10. 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 safety assessment limit | Breckenridge Pharmaceutical, Inc. / 1,829 60-count bottles | Class II | Ongoing |
| D-0547-2025 | 07-11-2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. | Nostrum Laboratories, Inc. / 60,608 bottles | Class II | Ongoing |
| D-0545-2025 | 07-10-2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04 Package NDCs: 60793-700-01; 60793-700-10; 60793-701-02; 60793-701-10; 60793-702-04; 60793-702-10 | CGMP Deviations; particulates identified during visual inspection | Pfizer Inc. / 19,279 vials | Class II | Ongoing |
| D-0544-2025 | 07-10-2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02 Package NDCs: 60793-700-01; 60793-700-10; 60793-701-02; 60793-701-10; 60793-702-04; 60793-702-10 | CGMP Deviations; particulates identified during visual inspection | Pfizer Inc. / 50,855 2 mL vials | Class II | Ongoing |
| D-0549-2025 | 07-10-2025 | Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194 Package NDCs: 42913-039-00; 8151950181 | CGMP Deviations | A.P. Deauville, LLC / 22,482 Cases | Class II | Ongoing |
| D-0548-2025 | 07-10-2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313 Package NDCs: 42913-038-00; 8151950193 | CGMP Deviations | A.P. Deauville, LLC / 21,265 cases | Class II | Ongoing |
| D-0550-2025 | 07-10-2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224 Package NDCs: 42913-040-00; 8151950182 | CGMP Deviations | A.P. Deauville, LLC / 23,467 Cases | Class II | Ongoing |
| D-0533-2025 | 07-09-2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18 Package NDCs: 67877-261-30; 67877-261-01; 67877-261-05; 67877-261-18; 67877-261-25; 67877-262-30; 67877-262-01; 67877-262-05; 67877-262-18; 67877-262-25 | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. | Ascend Laboratories, LLC / N/A | Class II | Ongoing |
| D-0546-2025 | 07-09-2025 | Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04 Package NDCs: 64380-883-04; 64380-884-04; 64380-885-04 | Failed Dissolution Specifications. | Strides Pharma, Inc. / 6,672 bottles | Class II | Ongoing |
| D-0536-2025 | 07-09-2025 | Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05. | Sub-Potent Drug: Subpotent assay results during stability testing. | Imprimis NJOF, LLC / 2,890 vials | Class III | Ongoing |
| D-0534-2025 | 07-09-2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18 Package NDCs: 67877-261-30; 67877-261-01; 67877-261-05; 67877-261-18; 67877-261-25; 67877-262-30; 67877-262-01; 67877-262-05; 67877-262-18; 67877-262-25 | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. | Ascend Laboratories, LLC / N/A | Class II | Ongoing |
| D-0535-2025 | 07-09-2025 | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01 | Sub-Potent Drug: Subpotent assay results during stability testing. | Imprimis NJOF, LLC / 6,880 vials | Class II | Ongoing |
| D-0543-2025 | 07-05-2025 | 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. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. | FDC Limited / 154,176 bottles | Class II | Ongoing |
| D-0542-2025 | 07-02-2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01. Package NDCs: 68180-755-01; 68180-755-02; 68180-755-03; 68180-756-01; 68180-756-02; 68180-756-03; 68180-459-01; 68180-459-02; 68180-459-03; 68180-472-01; 68180-472-02; 68180-472-03; 68180-463-01; 68180-463-02; 68180-463-03; 68180-473-01; 68180-473-02; 68180-473-03; 68180-759-01; 68180-759-02; 68180-759-03; 68180-760-01; 68180-760-02; 68180-760-03; 68180-757-01; 68180-757-02; 68180-757-03; 68180-758-01; 68180-758-02; 68180-758-03 | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 | Lupin Pharmaceuticals Inc. / 7668 bottles | Class II | Ongoing |
| D-0530-2025 | 07-01-2025 | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870. | Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented. | Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles / 2 bags | Class II | Ongoing |
| D-0525-2025 | 06-30-2025 | Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10 Package NDCs: 82009-022-10 | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. | Dr. Reddy's Laboratories, Inc. / 1476 bottles | Class II | Ongoing |
| D-0511-2025 | 06-30-2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33. 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. / 12,242 30-count bottles | Class II | Ongoing |
| D-0541-2025 | 06-30-2025 | Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton) Package NDCs: 69097-318-86; 69097-318-87; 69097-318-32; 69097-318-53; 69097-319-86; 69097-319-87; 69097-319-32; 69097-319-53; 69097-321-86; 69097-321-87; 69097-321-32; 69097-321-53 | Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. | Cipla USA, Inc. / 13,680 ampoules | Class II | Ongoing |
| D-0537-2025 | 06-27-2025 | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01 Package NDCs: 68180-492-01; 68180-492-07; 68180-492-09; 68180-492-06; 68180-493-01; 68180-493-07; 68180-493-09; 68180-493-06; 68180-494-01; 68180-494-07; 68180-494-09; 68180-494-06 | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. | Lupin Pharmaceuticals Inc. / 2,724 bottles | Class II | Ongoing |
| D-0570-2025 | 06-27-2025 | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94. Package NDCs: 0781-6135-94; 0781-6135-95; 0781-6136-94 | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit | Sandoz Inc / unknown | Class I | Ongoing |
| D-0569-2025 | 06-27-2025 | Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton). Package NDCs: 0781-3450-70; 0781-3450-95; 0781-3451-70; 0781-3451-96 | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin | Sandoz Inc / 208,300 vials | Class I | Ongoing |
| D-0529-2025 | 06-26-2025 | Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 Package NDCs: 42291-906-90; 42291-907-90; 42291-905-90 | Failed Impurity/Degradation Specifications | AvKARE / 8,573 bottles | Class III | Ongoing |
| D-0528-2025 | 06-26-2025 | Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90 Package NDCs: 42291-906-90; 42291-907-90; 42291-905-90 | Failed Impurity/Degradation Specifications | AvKARE / 1,560 bottles | Class III | Ongoing |
| D-0510-2025 | 06-24-2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, Package NDCs: 70010-780-01; 70010-780-05; 70010-780-10; 70010-781-01; 70010-781-05; 70010-781-10; 70010-782-01; 70010-782-05; 70010-782-10; 70010-783-01; 70010-783-05; 70010-783-10 | Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. | Granules Pharmaceuticals Inc. / 27,648 100-count Bottles; 5,376 500-count Bottles | Class II | Ongoing |
| D-0519-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 2,352 bottles | Class II | Ongoing |
| D-0521-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 9,739 bottles | Class II | Ongoing |
| D-0520-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 54,227 bottles | Class II | Ongoing |
| D-0532-2025 | 06-20-2025 | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01 Package NDCs: 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01 | Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg. | Lupin Pharmaceuticals Inc. / 58,968 bottles | Class II | Ongoing |
| D-0524-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 2,344 bottles | Class II | Ongoing |
| D-0523-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 4,921 bottles | Class II | Ongoing |
| D-0518-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 82,159 bottles | Class II | Ongoing |
| D-0522-2025 | 06-20-2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent Drug: Assay below the approved specification | ACCORD HEALTHCARE, INC. / 4,896 bottles | Class II | Ongoing |
| D-0508-2025 | 06-19-2025 | Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0 Package NDCs: 55154-3363-0; 55154-7992-0; 55154-7993-0 | Defective container; blister packaging inadequately sealed. | The Harvard Drug Group LLC / 3,527 bags | Class II | Ongoing |
| D-0507-2025 | 06-19-2025 | Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61 Package NDCs: 0904-6665-61; 0904-6666-61; 0904-6667-61 | Defective container; blister packaging inadequately sealed. | The Harvard Drug Group LLC / 23,232 cartons | Class II | Ongoing |
| D-0516-2025 | 06-16-2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88 Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). | SUN PHARMACEUTICAL INDUSTRIES INC / 5,448 bottles | Class II | Ongoing |
| D-0517-2025 | 06-16-2025 | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01 | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. | Qualgen, LLC / 2,832 amber vials | Class III | Ongoing |
| D-0491-2025 | 06-16-2025 | 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10 | Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. | B BRAUN MEDICAL INC / 187,656 containers | Class II | Ongoing |
| D-0509-2025 | 06-11-2025 | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07. Package NDCs: 33342-024-07; 33342-025-07; 33342-026-07 | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. | Macleods Pharmaceuticals Ltd / 9,888/ 30 count bottles | Class III | Ongoing |
| D-0527-2025 | 06-11-2025 | Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98. Package NDCs: 0480-3632-98; 0480-3633-98; 0480-3631-98 | Failed Impurities/Degradation Specifications. | Orient Pharma Co., Ltd. Yunlin Plant / 20618 bottles | Class III | Ongoing |
| D-0526-2025 | 06-11-2025 | Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98. Package NDCs: 0480-3632-98; 0480-3633-98; 0480-3631-98 | Failed Impurities/Degradation Specifications. | Orient Pharma Co., Ltd. Yunlin Plant / 57504 bottles | Class III | Ongoing |
| D-0505-2025 | 06-06-2025 | ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6 | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Church & Dwight Inc / 13,632 cartons | Class I | Ongoing |
| D-0506-2025 | 06-06-2025 | Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2. | Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. | Church & Dwight Inc / 695,880 cartons | Class I | Ongoing |
| D-0504-2025 | 06-06-2025 | ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5 | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Church & Dwight Inc / 3,374,918 cartons | Class I | Ongoing |
| D-0502-2025 | 06-02-2025 | LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 2825 vials | Class II | Ongoing |
| D-0503-2025 | 06-02-2025 | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 4875 vials | Class II | Ongoing |
| D-0488-2025 | 06-02-2025 | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Package NDCs: 65162-271-05; 65162-271-10; 65162-271-50; 65162-271-11; 65162-272-01; 65162-272-24; 65162-272-10; 65162-272-25; 65162-272-50 | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. | Amneal Pharmaceuticals, LLC / 6396 bottles | Class I | Ongoing |
| D-0501-2025 | 06-02-2025 | KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 14,725 vials | Class II | Ongoing |
| D-0500-2025 | 06-02-2025 | KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 23,200 vials | Class II | Ongoing |
| D-0498-2025 | 06-02-2025 | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 29,700 vials | Class II | Ongoing |
| D-0499-2025 | 06-02-2025 | BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0. | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. | Tailstorm Health INC / 975 vials | Class II | Ongoing |
| D-0531-2025 | 05-30-2025 | TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01 | Marketed Without an Approved NDA/ANDA | Advanced Pharmaceutical Technology, Inc. / 26 vials | Class II | Ongoing |
| D-0497-2025 | 05-30-2025 | Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7. Package NDCs: 70710-1738-4; 70710-1592-7 | Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents. | Zydus Pharmaceuticals (USA) Inc / 11,616 bottles | Class II | Ongoing |
| D-0470-2025 | 05-29-2025 | Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44. Package NDCs: 33342-393-10; 33342-393-11; 33342-393-44; 33342-394-10; 33342-394-11; 33342-394-44; 33342-395-10; 33342-395-11; 33342-395-44; 33342-396-10; 33342-396-11; 33342-396-44; 33342-397-10; 33342-397-11; 33342-397-44; 33342-398-10; 33342-398-11; 33342-398-44; 33342-399-10; 33342-399-11; 33342-399-44; 33342-400-10; 33342-400-11; 33342-400-44; 33342-401-10; 33342-401-11; 33342-401-44; 33342-402-10; 33342-402-11; 33342-402-44; 33342-403-10; 33342-403-11; 33342-403-44; 33342-404-10; 33342-404-11; 33342-404-44 | Presence of a foreign substance: black hair found embedded in tablet. | Macleods Pharmaceuticals Ltd / 1,344- 1000 count bottles | Class III | Ongoing |
| D-0472-2025 | 05-29-2025 | Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25 Package NDCs: 55150-401-01; 55150-401-25 | Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. | Eugia US LLC / 48,000 vials | Class II | Ongoing |
| D-0494-2025 | 05-28-2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 Package NDCs: 60505-1003-1; 60505-1003-2 | Lack of Assurance of Sterility | Apotex Corp. / 87,840 bottles | Class II | Ongoing |
| D-0496-2025 | 05-28-2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3 Package NDCs: 60505-0589-1; 60505-0589-2; 60505-0589-3 | Lack of Assurance of Sterility | Apotex Corp. / 6,288 Bottles | Class II | Ongoing |
| D-0489-2025 | 05-28-2025 | DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62 Package NDCs: 0409-2344-01; 0409-2344-62; 0409-2344-02 | Discoloration; discolored solution from cracked vials | Pfizer Inc. / 98,410 vials | Class II | Ongoing |
| D-0457-2025 | 05-28-2025 | Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4 Package NDCs: 60505-0405-6; 60505-0405-4 | Defective Container: This recall is being initiated due to a leaking unit stored horizontally. | Apotex Corp. / 20,648 bottles | Class II | Ongoing |
| D-0495-2025 | 05-28-2025 | Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 Package NDCs: 60505-0578-4 | Lack of Assurance of Sterility | Apotex Corp. / 105,456 Bottles | Class II | Ongoing |
| D-0490-2025 | 05-27-2025 | 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10 Package NDCs: 49230-300-10 | Lack of Assurance of Sterility | Fresenius Medical Care Holdings, Inc. / 3,651,468 containers | Class II | Ongoing |
