FDA Drug · 2018
FDA Drug recalls in 2018
RecallRadar indexes 1,426 FDA Drug recall notices published in 2018. By classification: 107 Class I, 1,166 Class II, 153 Class III.
- Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee,…
FDA Drug · Class II · 2018-02-07 · Premier Pharmacy Labs - BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
FDA Drug · Class I · 2018-02-07 · Blue Fusion Natural - Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 5445…
FDA Drug · Class I · 2018-02-07 · International Laboratories - Medline General Purpose Instrument Set, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Medline Suture Removal Tray, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Medline Skin Stapler RMVR, Tray Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
FDA Drug · Class II · 2018-02-07 · A And H Focal - Medline Skin Biopsy Pack-LF, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Medline Suture Removal Tray, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Medline CNTRL Line Removal Kit Scripps
FDA Drug · Class II · 2018-02-07 · Medline Industries - Medline Suture Removal Kit, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Medline Incision Drainage Tray, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manu…
FDA Drug · Class III · 2018-02-07 · Ascent Pharmaceuticals - Medline Hip Replacement, Kit, Sterile, Single Use Only
FDA Drug · Class II · 2018-02-07 · Medline Industries - Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispen…
FDA Drug · Class II · 2018-01-31 · International Laboratories - Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distribute…
FDA Drug · Class I · 2018-01-31 · Www Blankterrmall Com - BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
FDA Drug · Class I · 2018-01-31 · Botanicalnow - Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispen…
FDA Drug · Class II · 2018-01-31 · International Laboratories - Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…
FDA Drug · Class II · 2018-01-31 · Marksans Pharma - Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar
FDA Drug · Class II · 2018-01-31 · Odan Laboratories - Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by:…
FDA Drug · Class II · 2018-01-31 · Dlc Laboratories - Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…
FDA Drug · Class II · 2018-01-31 · Marksans Pharma - bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc
FDA Drug · Class III · 2018-01-31 · Mylan Pharmaceuticals - Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging,…
FDA Drug · Class II · 2018-01-31 · Marksans Pharma - Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…
FDA Drug · Class II · 2018-01-31 · Marksans Pharma - Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…
FDA Drug · Class II · 2018-01-31 · Marksans Pharma - Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale
FDA Drug · Class II · 2018-01-31 · Odan Laboratories - MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Housto…
FDA Drug · Class I · 2018-01-31 · Advanced Pharma - DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries ,…
FDA Drug · Class II · 2018-01-31 · Sun Pharmaceutical Industries - Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…
FDA Drug · Class II · 2018-01-31 · Marksans Pharma - Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%)…
FDA Drug · Class II · 2018-01-24 · Shiseido America - Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177…
FDA Drug · Class II · 2018-01-24 · Pharmatech - Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories,…
FDA Drug · Class II · 2018-01-24 · Pharmatech - Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged i…
FDA Drug · Class II · 2018-01-24 · Shiseido America - Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories,…
FDA Drug · Class II · 2018-01-24 · Pharmatech - Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, M…
FDA Drug · Class II · 2018-01-24 · Pharmedium Services - Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufact…
FDA Drug · Class III · 2018-01-24 · Hetero Labs Unit Iii - ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count ca…
FDA Drug · Class II · 2018-01-24 · Pharmedium Services - Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packa…
FDA Drug · Class II · 2018-01-24 · Shiseido America - Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd
FDA Drug · Class II · 2018-01-24 · Unichem Pharmaceuticals Usa - Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc
FDA Drug · Class II · 2018-01-24 · Avkare - Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo P…
FDA Drug · Class III · 2018-01-24 · Shionogi - Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories,…
FDA Drug · Class II · 2018-01-24 · Pharmatech - Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc ox…
FDA Drug · Class II · 2018-01-24 · Shiseido America - bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Es…
FDA Drug · Class II · 2018-01-24 · Shiseido America - QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only,…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury,…
FDA Drug · Class II · 2018-01-17 · Solco Healtcare Us - Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by
FDA Drug · Class II · 2018-01-17 · Allergan - 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, F…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Comme…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SM…
FDA Drug · Class II · 2018-01-17 · Pfizer Manufacturing Deutschland - Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca R…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box
FDA Drug · Class II · 2018-01-17 · Medex Cardio Pulmonary D B A Smiths Medical - PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 334…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rat…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, B…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Comm…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only
FDA Drug · Class III · 2018-01-17 · Akorn - Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zheji…
FDA Drug · Class II · 2018-01-17 · Prinston Pharmaceutical - Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Bl…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICA…
FDA Drug · Class II · 2018-01-17 · Teva Pharmaceuticals Usa - Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Bo…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box
FDA Drug · Class II · 2018-01-17 · Medex Cardio Pulmonary D B A Smiths Medical - Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rat…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box
FDA Drug · Class II · 2018-01-17 · Medex Cardio Pulmonary D B A Smiths Medical - Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton,…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commer…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis,…
FDA Drug · Class III · 2018-01-17 · Sanofi Aventis U S - Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoe…
FDA Drug · Class II · 2018-01-17 · Sca Pharmaceuticals - Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rato…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arling…
FDA Drug · Class II · 2018-01-17 · Woodfield Pharmaceutical - Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rato…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, F…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS G…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology - Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box
FDA Drug · Class II · 2018-01-17 · Medex Cardio Pulmonary D B A Smiths Medical - Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only,…
FDA Drug · Class II · 2018-01-17 · Krs Global Biotechnology
Other years
2026 (565) · 2025 (765) · 2024 (657) · 2023 (1,252) · 2022 (1,349) · 2021 (1,016) · 2020 (1,035) · 2019 (2,152) · 2018 (1,426) · 2017 (1,073) · 2016 (1,254) · 2015 (2,020) · 2014 (1,562) · 2013 (1,377) · 2012 (434)