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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0053-2026 | 07-30-2025 | Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 907 | Class II | Ongoing |
| D-0056-2026 | 07-30-2025 | L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 83 | Class II | Ongoing |
| D-0062-2026 | 07-30-2025 | Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 430 | Class II | Ongoing |
| D-0075-2026 | 07-30-2025 | Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI). | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0051-2026 | 07-30-2025 | GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 221 | Class II | Ongoing |
| D-0081-2026 | 07-30-2025 | Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0063-2026 | 07-30-2025 | Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 30 | 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-0092-2026 | 07-30-2025 | Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0050-2026 | 07-30-2025 | GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 3 | Class II | Ongoing |
| D-0047-2026 | 07-30-2025 | B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0620-2025 | 07-30-2025 | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton) Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5012-1 | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. | Exela Pharma Sciences LLC / N/A | 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-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-0598-2025 | 07-29-2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] | 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. | Amerisource Health Services LLC / 26,992 blister packs | 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-0659-2025 | 07-21-2025 | Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788. | cGMP Deviations | YANGZHOU YULOU PAPER PRODUCTS CO., LTD / 500 cases | 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-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-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-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-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-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-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-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-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-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-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-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-0610-2025 | 07-17-2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 11,321 bag in boxes | Class I | Ongoing |
| D-0613-2025 | 07-17-2025 | PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 5,703 bottles | Class I | Ongoing |
| D-0612-2025 | 07-17-2025 | KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 6,973 cartridges | Class I | Ongoing |
| D-0611-2025 | 07-17-2025 | DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 249 bottles | Class I | 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-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 | CGMP Deviations | A.P. Deauville, LLC / 23,467 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 | CGMP Deviations | A.P. Deauville, LLC / 21,265 cases | 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 | CGMP Deviations | A.P. Deauville, LLC / 22,482 Cases | 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-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 | Completed |
| 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-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-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 | Completed |
| D-0606-2025 | 07-09-2025 | Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy | Subpotent Drug | Boothwyn Pharmacy LLC / 642 vials | Class II | Ongoing |
| D-0609-2025 | 07-09-2025 | Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy | Subpotent Drug | Boothwyn Pharmacy LLC / 648 vials | Class II | Ongoing |
| D-0608-2025 | 07-09-2025 | Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy | Subpotent Drug | Boothwyn Pharmacy LLC / 186 vials | Class II | Ongoing |
| D-0607-2025 | 07-09-2025 | Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 | Subpotent Drug | Boothwyn Pharmacy LLC / 8 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-0604-2025 | 07-07-2025 | Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78. Package NDCs: 46122-043-78; 6122407007 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 66,000 pads | Class II | Ongoing |
| D-0603-2025 | 07-07-2025 | H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09. Package NDCs: 37808-809-30; 37808-809-60; 37808-809-09; 6122408004 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 300000 pads | Class II | Ongoing |
| D-0602-2025 | 07-07-2025 | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60. Package NDCs: 49035-814-30; 49035-814-60; 6122407007 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 3,456,000 pads | Class II | Ongoing |
| D-0605-2025 | 07-07-2025 | RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2. Package NDCs: 11822-5156-6; 11822-5156-2; 6122407008 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 984,000 pads | Class II | Ongoing |
| D-0600-2025 | 07-07-2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. Package NDCs: 53329-811-30; 53329-811-09; 6122404005 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 6669874 swabs | Class II | Ongoing |
| D-0601-2025 | 07-07-2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30 Package NDCs: 53329-827-60; 53329-827-36; 53329-827-30; 53329-827-29; 53329-827-40; 53329-827-09; 53329-827-33; 6122405000 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 1,639,996 pads | 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 | Terminated |
| 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-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-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-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; 0781-3451-95 | 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-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 | Terminated |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0614-2025 | 06-10-2025 | KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026 | Subpotent Drug | IMMUNOCORE, LLC / 7,572 vials | Class II | 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-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-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-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-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-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-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-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-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 |
