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-0861-2021 | 08-20-2021 | Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. Marketed by: Health Specialty | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3 Liter bottles | Class II | Terminated |
| D-0865-2021 | 08-20-2021 | Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1 OZ, UPC 7 40640 28177 2, b) 4 dr, UPC 7 40640 28173 4; 10X Packaged as c) 4 dr; 15X Packaged as d) 1 OZ; 30X Packaged as e) 2 Dram, UPC 7 40640 28171 0, f) 4 dr, UPC 7 40640 28175 8; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 17 bottles | Class II | Terminated |
| D-0888-2021 | 08-20-2021 | ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/liter | Class II | Terminated |
| D-0773-2021 | 08-19-2021 | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 Package NDCs: 0002-1433-01; 0002-1433-80; 0002-1433-61; 0002-1434-01; 0002-1434-80; 0002-1434-61; 0002-2236-01; 0002-2236-80; 0002-2236-61; 0002-3182-01; 0002-3182-80; 0002-3182-61 | Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. | Eli Lilly & Company / 119,539 4-packs | Class II | Terminated |
| D-0794-2021 | 08-19-2021 | Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01 Package NDCs: 42858-001-01; 42858-001-10; 42858-002-01; 42858-002-10; 42858-003-01; 42858-004-01; 42858-005-01 | Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle | Rhodes Pharmaceuticals, L.P. / 55,344/100 count bottles | Class II | Terminated |
| D-0804-2021 | 08-18-2021 | Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy | Lack of Assurance of Sterility | Prescription Labs Inc dba Greenpark / 350 bottles | Class II | Terminated |
| D-0819-2021 | 08-18-2021 | X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2 | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | Phe Inc / 15000 packets | Class I | Completed |
| D-0754-2021 | 08-17-2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01 | A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles. | RemedyRepack Inc. / 4 | Class II | Terminated |
| D-0753-2021 | 08-13-2021 | Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05 Package NDCs: 68382-092-17; 68382-092-01; 68382-092-05; 68382-093-17; 68382-093-05; 68382-093-01; 68382-094-17; 68382-094-01; 68382-094-05; 68382-095-17; 68382-095-01; 68382-095-05 | Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle | Zydus Pharmaceuticals (USA) Inc / 2880 bottles | Class II | Terminated |
| D-0050-2022 | 08-13-2021 | TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0051-2022 | 08-13-2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0049-2022 | 08-13-2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0037-2022 | 08-13-2021 | ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0033-2022 | 08-13-2021 | ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0054-2022 | 08-13-2021 | ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0066-2022 | 08-13-2021 | PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0030-2022 | 08-13-2021 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0063-2022 | 08-13-2021 | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0056-2022 | 08-13-2021 | CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0053-2022 | 08-13-2021 | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0055-2022 | 08-13-2021 | BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0041-2022 | 08-13-2021 | PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0042-2022 | 08-13-2021 | TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0038-2022 | 08-13-2021 | GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0067-2022 | 08-13-2021 | SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0048-2022 | 08-13-2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0059-2022 | 08-13-2021 | METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0058-2022 | 08-13-2021 | METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0061-2022 | 08-13-2021 | METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0029-2022 | 08-13-2021 | Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0040-2022 | 08-13-2021 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0802-2021 | 08-13-2021 | Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701 | Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. | Akorn, Inc. / 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289 | Class II | Terminated |
| D-0052-2022 | 08-13-2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0766-2021 | 08-13-2021 | Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4 Package NDCs: 42794-086-14 | Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. | SigmaPharm Laboratories LLC / 1,993 bottles | Class II | Terminated |
| D-0060-2022 | 08-13-2021 | METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0034-2022 | 08-13-2021 | CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0065-2022 | 08-13-2021 | MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0045-2022 | 08-13-2021 | TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0028-2022 | 08-13-2021 | Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0035-2022 | 08-13-2021 | CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0039-2022 | 08-13-2021 | HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0062-2022 | 08-13-2021 | MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0036-2022 | 08-13-2021 | DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0046-2022 | 08-13-2021 | TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0047-2022 | 08-13-2021 | TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0044-2022 | 08-13-2021 | TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0032-2022 | 08-13-2021 | ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0064-2022 | 08-13-2021 | MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0043-2022 | 08-13-2021 | TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0031-2022 | 08-13-2021 | ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0057-2022 | 08-13-2021 | FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0809-2021 | 08-13-2021 | Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56. Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0811-2021 | 08-13-2021 | Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0810-2021 | 08-13-2021 | Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56. Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0808-2021 | 08-13-2021 | Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets. | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0755-2021 | 08-12-2021 | Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10 | Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured. | ANHUI WELCOME FOREIGN TRADE CO.,LTD. / 63,750 | Class II | Terminated |
| D-0797-2021 | 08-11-2021 | Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108 | Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine | Ebay Seller - John Nguyen / 35 boxes | Class I | Terminated |
| D-0777-2021 | 08-11-2021 | Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36 | CGMP Deviations | Granules USA, Inc. / 11,450,000 tablets | Class II | Terminated |
| D-0767-2021 | 08-10-2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01 | Non-Sterility: firm's third party lab confirmed microbial contamination. | SterRx, LLC / 1098 bags | Class I | Terminated |
| D-0768-2021 | 08-10-2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 | Lack of Assurance of Sterility | SterRx, LLC / 3378 bags | Class II | Terminated |
| D-0756-2021 | 08-06-2021 | Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01 Package NDCs: 70594-037-01; 70594-036-01 | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations. | XELLIA PHARMACEUTICALS USA, LLC / 9,161 vials 50 mg and 100 mg vials total | Class II | Terminated |
| D-0757-2021 | 08-06-2021 | Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01 Package NDCs: 70594-037-01; 70594-036-01 | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations. | XELLIA PHARMACEUTICALS USA, LLC / 9,161 (50mg and 100 mg vials total) | Class II | Terminated |
| D-0807-2021 | 08-06-2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61 Package NDCs: 0904-3854-61; 0904-3854-80; 0904-6172-61; 0904-6172-50 | Failed Dissolution Specifications | The Harvard Drug Group / 4 Cartons of 100 count each | Class II | Terminated |
| D-0728-2021 | 08-05-2021 | Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711 | Out of specification results for conductivity. | DuPont Nutrition USA, Inc / 2,384,720 kg | Class III | Terminated |
| D-0771-2021 | 08-05-2021 | Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01 Package NDCs: 0143-9240-01; 0143-9241-01 | Labeling: Not elsewhere classified: Mislabeling | Hikma Pharmaceuticals USA Inc. / 1,152 vials | Class III | Terminated |
| D-0289-2022 | 08-03-2021 | Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40 | Failed Impurities/Degradation Specifications | The Harvard Drug Group / 2,239 bottles | Class II | Terminated |
| D-0800-2021 | 08-03-2021 | Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50. | Superpotent Drug | Teligent Pharma, Inc. / 32,544 glass bottles | Class I | Ongoing |
| D-0631-2022 | 08-02-2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns. | Je Dois Lavoir LLC / 783 bottles | Class I | Terminated |
| D-0787-2021 | 08-02-2021 | Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15 Package NDCs: 33342-060-07; 33342-060-15; 33342-060-12; 33342-060-10; 33342-060-44 | Presence of foreign matter | Macleods Pharma Usa Inc / 444,000 tablets / 888 unit packs of 500 count | Class II | Terminated |
| D-0786-2021 | 08-02-2021 | Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35 | Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group. | Akorn, Inc. / 142,188 tubes | Class II | Terminated |
| D-0765-2021 | 07-30-2021 | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01 | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. | Custopharm, Inc. / 19,384 vials | Class II | Terminated |
| D-0724-2021 | 07-30-2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 Package NDCs: 68968-0514-8; 68968-0525-8; 68968-0514-2 | Failed Stability Specifications; out of specification for shear. | Noven Pharmaceuticals Inc / 223,382 boxes | Class II | Ongoing |
| D-0725-2021 | 07-30-2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 Package NDCs: 68968-0514-8; 68968-0525-8; 68968-0525-2 | Failed Stability Specifications; out of specification for shear. | Noven Pharmaceuticals Inc / 70,638 boxes | Class II | Ongoing |
| D-0702-2021 | 07-30-2021 | Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837 | Lack of sterility assurance | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy / 253 syringes | Class II | Terminated |
| D-0732-2021 | 07-29-2021 | Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 16,226 vials | Class II | Terminated |
| D-0806-2021 | 07-29-2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04 Package NDCs: 0904-6822-04; 0904-6822-07 | Failed Dissolution Specifications | The Harvard Drug Group / 1,632 cartons | Class II | Terminated |
| D-0723-2021 | 07-29-2021 | Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16 Package NDCs: 0121-0670-16 | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 75 cases (6 bottles/case) | Class II | Terminated |
| D-0721-2021 | 07-29-2021 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 Package NDCs: 0121-0868-02; 0121-0868-16; 0121-0868-05; 0121-0868-40; 0121-0868-50; 0121-0868-00 | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case) | Class II | Terminated |
| D-0703-2021 | 07-29-2021 | Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01 | Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg | SUN PHARMACEUTICAL INDUSTRIES INC / 2856 bottles | Class II | Terminated |
| D-0722-2021 | 07-29-2021 | Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08 | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 400 cases (12 bottles/case) | Class II | Terminated |
| D-0776-2021 | 07-29-2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01 | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. | Teva Pharmaceuticals USA / 4,992 bottles | Class II | Terminated |
| D-0775-2021 | 07-29-2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01 | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. | Teva Pharmaceuticals USA / 4,587 bottles | Class II | Terminated |
| D-0726-2021 | 07-29-2021 | GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19 Package NDCs: 43386-060-19 | Failed Stability Specification; Out of specification for Osmolarity | Novel Laboratories, Inc. d.b.a LUPIN / 20,814 bottles | Class II | Terminated |
| D-0769-2021 | 07-29-2021 | Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59 | Defective container: possibility for lack of seal integrity. | Teligent Pharma, Inc. / 7488 bottles | Class II | Ongoing |
| D-0734-2021 | 07-29-2021 | Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 2,091 vials | Class II | Terminated |
| D-0741-2021 | 07-29-2021 | Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01 Package NDCs: 0703-4502-01; 0703-4502-04 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 25,653 vials | Class II | Terminated |
| D-0739-2021 | 07-29-2021 | Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 34,100 vials | Class II | Terminated |
| D-0733-2021 | 07-29-2021 | Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 4,712 vials | Class II | Terminated |
| D-0746-2021 | 07-29-2021 | Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 476,275 vials | Class II | Terminated |
| D-0740-2021 | 07-29-2021 | Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 4,249 vials | Class II | Terminated |
| D-0730-2021 | 07-29-2021 | DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 1,351 vials | Class II | Terminated |
| D-0744-2021 | 07-29-2021 | Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 3,067 vials | Class II | Terminated |
| D-0747-2021 | 07-29-2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 42,046 vials | Class II | Terminated |
| D-0731-2021 | 07-29-2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 193,845 vials | Class II | Terminated |
| D-0735-2021 | 07-29-2021 | Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 62,358 vials | Class II | Terminated |
| D-0785-2021 | 07-29-2021 | Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14. | Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing. | Teligent Pharma, Inc. / 114,456 tubes | Class III | Terminated |
| D-0745-2021 | 07-29-2021 | Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 6,184 vials | Class II | Terminated |
| D-0748-2021 | 07-29-2021 | Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 20,800 vials | Class II | Terminated |
| D-0743-2021 | 07-29-2021 | Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 50,713 vials | Class II | Terminated |
| D-0737-2021 | 07-29-2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 434,229 vials | Class II | Terminated |
