DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20191113
BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075 Basic Reset Inc. Class II Terminated 20191113
Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN. Basic Reset Inc. Class II Terminated 20191113
Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075. Basic Reset Inc. Class II Terminated 20191113
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05 Mylan Pharmaceuticals Inc. Class II Terminated 20191113
Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC) Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC) Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01) Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC. Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC. Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720 Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05) Dr. Reddy's Laboratories, Inc. Class II Completed 20191113
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028 FITOTERAPIA USA, INC Class I Terminated 20191106
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20191106
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20191106
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20191106