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 July 25, 2025 and include a total of 16975 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-0455-2025 | 05-27-2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 Package NDCs: 13668-443-74; 13668-443-10; 13668-443-01; 13668-443-30; 13668-443-91; 13668-473-10; 13668-473-74; 13668-473-30; 13668-473-01; 13668-473-91 | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Torrent Pharma Inc. / 3672 Bottles | Class II | Ongoing |
| D-0456-2025 | 05-27-2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) Package NDCs: 13668-443-74; 13668-443-10; 13668-443-01; 13668-443-30; 13668-443-91; 13668-473-10; 13668-473-74; 13668-473-30; 13668-473-01; 13668-473-91; 13668-473-70 | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Torrent Pharma Inc. / 972 Cartons | Class II | Ongoing |
| D-0469-2025 | 05-23-2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. | Ascend Laboratories, LLC / 10,620 - 200 mL bottles | Class II | Ongoing |
| D-0468-2025 | 05-23-2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. | Ascend Laboratories, LLC / 48,936 - 100 mL bottles | Class II | Ongoing |
| D-0458-2025 | 05-23-2025 | Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5 Package NDCs: 53329-202-13; 53329-202-04; 53329-202-08; 53329-202-70; 53329-202-84; 53329-202-85; 53329-202-74 | Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol | Consumer Product Partners, LLC / 125,040 bottles | Class II | Ongoing |
| D-0473-2025 | 05-23-2025 | Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01. Package NDCs: 0093-2204-01; 0093-2204-05; 0093-2203-01; 0093-2203-05; 0093-2203-10 | Presence of foreign tablets/capsules. | Teva Pharmaceuticals USA, Inc / 36612 cartons | Class II | Ongoing |
| D-0471-2025 | 05-22-2025 | Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10 Package NDCs: 72288-405-10 | cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). | Aurobindo Pharma USA Inc / 4,608 bottles | Class II | Ongoing |
| D-0485-2025 | 05-21-2025 | Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 216 syringes | Class II | Ongoing |
| D-0478-2025 | 05-21-2025 | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 16 syringes | Class II | Ongoing |
| D-0483-2025 | 05-21-2025 | Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 826 syringes | Class II | Ongoing |
| D-0492-2025 | 05-21-2025 | UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295 | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole. | Umary-USA.com / 1,342 30-count bottles | Class I | Ongoing |
| D-0474-2025 | 05-21-2025 | Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 5 | Class II | Ongoing |
| D-0493-2025 | 05-21-2025 | UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134 | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac. | Umary-USA.com / 1,704 30-count bottles | Class I | Ongoing |
| D-0480-2025 | 05-21-2025 | Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 164 syringes | Class II | Ongoing |
| D-0487-2025 | 05-21-2025 | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 16 syringes | Class II | Ongoing |
| D-0477-2025 | 05-21-2025 | LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 102 syringes | Class II | Ongoing |
| D-0484-2025 | 05-21-2025 | Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 4 syringes | Class II | Ongoing |
| D-0486-2025 | 05-21-2025 | Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 242 syringes | Class II | Ongoing |
| D-0482-2025 | 05-21-2025 | Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 24 syringes | Class II | Ongoing |
| D-0481-2025 | 05-21-2025 | Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 28 syringes | Class II | Ongoing |
| D-0475-2025 | 05-21-2025 | CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 60 syringes | Class II | Ongoing |
| D-0479-2025 | 05-21-2025 | Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 32 syringes | Class II | Ongoing |
| D-0476-2025 | 05-21-2025 | LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 | Lack of Assurance of Sterility | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) / 64 syringes | Class II | Ongoing |
| D-0462-2025 | 05-19-2025 | Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90 Package NDCs: 68462-321-90; 68462-321-10; 68462-321-30; 68462-322-30; 68462-322-90; 68462-322-10; 68462-323-30; 68462-323-90; 68462-323-05; 68462-324-30; 68462-324-90; 68462-324-05 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study. | Glenmark Pharmaceuticals Inc., USA / 6,759 Con - 90 bottle pack | Class III | Ongoing |
| D-0441-2025 | 05-15-2025 | BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31. Package NDCs: 54365-400-31 | Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. | CareFusion 213, LLC / 385,200 applicators | Class II | Ongoing |
| D-0452-2025 | 05-15-2025 | Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01 Package NDCs: 68462-380-01; 68462-380-05; 68462-356-01; 68462-356-05 | OOS results reported for the Dissolution (by UV) test. | Glenmark Pharmaceuticals Inc., USA / 8,520 100-count bottles | Class II | Ongoing |
| D-0454-2025 | 05-15-2025 | Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card). Package NDCs: 68084-411-11; 68084-411-21 | cGMP deviations | Amerisource Health Services LLC / 21 cartons | Class II | Ongoing |
| D-0444-2025 | 05-14-2025 | Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, . Package NDCs: 0310-9080-12; 0310-9080-28 | Defective delivery system | AsttraZeneca Pharmaceuticals LP / a) 807,837 canisters; b) 235,698 canisters | Class II | Ongoing |
| D-0460-2025 | 05-13-2025 | Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 Package NDCs: 50268-168-11; 50268-168-15; 50268-169-11; 50268-169-15 | Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules | AvKARE / 3,817 50-count cartons | Class II | Ongoing |
| D-0442-2025 | 05-13-2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94 Package NDCs: 68382-848-94; 68382-849-94 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. | Zydus Pharmaceuticals (USA) Inc / 30,674 30 sachets/carton | Class II | Ongoing |
| D-0443-2025 | 05-13-2025 | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94 Package NDCs: 68382-848-94; 68382-849-94 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. | Zydus Pharmaceuticals (USA) Inc / 22,152 30 sachets/carton | Class II | Ongoing |
| D-0446-2025 | 05-09-2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01. Package NDCs: 10702-026-03; 10702-026-01; 10702-026-10; 10702-027-03; 10702-027-01; 10702-027-10; 10702-028-03; 10702-028-01; 10702-028-10 | cGMP deviations | KVK Tech, Inc. / 9680 bottles | Class II | Ongoing |
| D-0445-2025 | 05-09-2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01. Package NDCs: 10702-016-03; 10702-016-06; 10702-016-09; 10702-016-01; 10702-016-50; 10702-016-10 | cGMP deviations | KVK Tech, Inc. / 9107 bottles | Class II | Ongoing |
| D-0461-2025 | 05-09-2025 | Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15 Package NDCs: 50268-167-11; 50268-167-15 | Failed Dissolution Specifications | AvKARE / 962 cartons | Class II | Ongoing |
| D-0459-2025 | 05-09-2025 | Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71 Package NDCs: 62332-140-30; 62332-140-60; 62332-140-91; 62332-140-08; 62332-140-10; 62332-141-30; 62332-141-31; 62332-141-91; 62332-141-08; 62332-141-10; 62332-141-60; 62332-141-71; 62332-142-30; 62332-142-31; 62332-142-91; 62332-142-71; 62332-142-08; 62332-142-10; 62332-142-60; 62332-143-30; 62332-143-60; 62332-143-71; 62332-143-10; 62332-143-14; 2405014780 | Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule | Alembic Pharmaceuticals Limited / 2,946 500-count bottles | Class II | Ongoing |
| D-0447-2025 | 05-07-2025 | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17 Package NDCs: 62332-508-17 | Failed Impurities/Degradation Specifications | Alembic Pharmaceuticals Limited / N/A | Class II | Ongoing |
| D-0453-2025 | 05-06-2025 | ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N | Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue). | EnShiShiXiangNiShangMaoYouXianGongSi / 600, 20-count cartons | Class I | Ongoing |
| D-0420-2025 | 05-02-2025 | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364. | Lack of Assurance of Sterility | Empower Clinic Services, LLC dba Empower Pharmacy / 8,230 vials | Class II | Ongoing |
| D-0412-2025 | 04-28-2025 | TESTOSTERONE PELLET 100 mg (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 2,762 vials | Class II | Ongoing |
| D-0413-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 1,974 vials | Class II | Ongoing |
| D-0410-2025 | 04-28-2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01. | CGMP Deviations | Siddha Flower Essences, LLC. / N/A | Class II | Ongoing |
| D-0416-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01 | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 1,964 vials | Class II | Ongoing |
| D-0414-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 355 vials | Class II | Ongoing |
| D-0415-2025 | 04-28-2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol | Presence of Particulate Matter: Glass particles were found in pellet vials. | BSO LLC / 1,447 vials | Class II | Ongoing |
| D-0401-2025 | 04-25-2025 | Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1 Package NDCs: 54643-5649-1; 54643-5657-1; 54643-5659-1; 54643-5650-2; 54643-5661-2; 54643-5663-2 | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. | Mckesson Medical-Surgical Inc. Corporate Office / 15 | Class II | Ongoing |
| D-0400-2025 | 04-25-2025 | Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01 | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product. | Mckesson Medical-Surgical Inc. Corporate Office / 3 | Class II | Ongoing |
| D-0439-2025 | 04-24-2025 | Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04 Package NDCs: 53247-131-01; 53247-131-02; 53247-131-03; 53247-131-04; 53247-131-05; 53247-131-06; 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 150,768 Tubes | Class II | Ongoing |
| D-0427-2025 | 04-24-2025 | Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6. Package NDCs: 55758-300-07; 55758-300-01 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 6,372 Tubes | Class II | Ongoing |
| D-0431-2025 | 04-24-2025 | Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02 Package NDCs: 53247-132-01; 53247-132-02; 53247-132-03; 53247-132-04; 53247-132-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 391,680 Tubes | Class II | Ongoing |
| D-0423-2025 | 04-24-2025 | CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 10,788 Tubes | Class II | Ongoing |
| D-0424-2025 | 04-24-2025 | Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6. Package NDCs: 55758-423-15 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 9,000 Bottles | Class II | Ongoing |
| D-0430-2025 | 04-24-2025 | Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01 Package NDCs: 53247-133-01 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 383,904 Tubes | Class II | Ongoing |
| D-0428-2025 | 04-24-2025 | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2. Package NDCs: 55758-420-02 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 10,000 Tubes | Class II | Ongoing |
| D-0436-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02 Package NDCs: 53247-131-01; 53247-131-02; 53247-131-03; 53247-131-04; 53247-131-05; 53247-131-06; 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 498,960 Tubes | Class II | Ongoing |
| D-0440-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05 Package NDCs: 53247-131-01; 53247-131-02; 53247-131-03; 53247-131-04; 53247-131-05; 53247-131-06; 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 160,848 Tubes | Class II | Ongoing |
| D-0429-2025 | 04-24-2025 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9. Package NDCs: 55758-440-02 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 9,336 Tubes | Class II | Ongoing |
| D-0437-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07 Package NDCs: 53247-131-01; 53247-131-02; 53247-131-03; 53247-131-04; 53247-131-05; 53247-131-06; 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 4,176 boxes | Class II | Ongoing |
| D-0435-2025 | 04-24-2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06 Package NDCs: 53247-131-01; 53247-131-02; 53247-131-03; 53247-131-04; 53247-131-05; 53247-131-06; 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 19,500 Tubes | Class II | Ongoing |
| D-0422-2025 | 04-24-2025 | CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 10,128 Bottles | Class II | Ongoing |
| D-0425-2025 | 04-24-2025 | KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0. | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 16,248 Jars | Class II | Ongoing |
| D-0433-2025 | 04-24-2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01 Package NDCs: 53247-132-01; 53247-132-02; 53247-132-03; 53247-132-04; 53247-132-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 1,559,000 Sachets | Class II | Ongoing |
| D-0421-2025 | 04-24-2025 | Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3. Package NDCs: 55758-030-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 9,984 Tubes | Class II | Ongoing |
| D-0438-2025 | 04-24-2025 | Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03 Package NDCs: 53247-131-01; 53247-131-02; 53247-131-03; 53247-131-04; 53247-131-05; 53247-131-06; 53247-131-07 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 616,160 Tubes | Class II | Ongoing |
| D-0432-2025 | 04-24-2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03 Package NDCs: 53247-132-01; 53247-132-02; 53247-132-03; 53247-132-04; 53247-132-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 615, 600 Tubes | Class II | Ongoing |
| D-0434-2025 | 04-24-2025 | Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04 Package NDCs: 53247-132-01; 53247-132-02; 53247-132-03; 53247-132-04; 53247-132-05 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 216,720 Tubes | Class II | Ongoing |
| D-0426-2025 | 04-24-2025 | KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3. Package NDCs: 55758-109-02 | CGMP Deviations | KENIL HEALTHCARE PRIVATE LIMITED / 11,808 Jars | Class II | Ongoing |
| D-0405-2025 | 04-23-2025 | Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15. Package NDCs: 50268-066-15 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 1,610 cases (24 cartons per case) | Class II | Ongoing |
| D-0404-2025 | 04-23-2025 | Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15. Package NDCs: 50268-043-15 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 13,872 cases (24 cartons per case) | Class II | Ongoing |
| D-0407-2025 | 04-23-2025 | Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15. Package NDCs: 50268-126-15 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 13,104 cases (24 cartons per case) | Class II | Ongoing |
| D-0406-2025 | 04-23-2025 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15. Package NDCs: 50268-068-15; 50268-068-02 | cGMP deviations and lack of assurance of sterility. | BRS Analytical Services, LLC / 32,876 cases (24 cartons per case) | Class II | Ongoing |
