FDA Drug · 2019
FDA Drug recalls in 2019
RecallRadar indexes 2,152 FDA Drug recall notices published in 2019. By classification: 511 Class I, 1,497 Class II, 144 Class III.
- Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-PROCAINE HCL 1% BUFFERED MDV
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial
FDA Drug · Class II · 2019-11-13 · First Royal Care - 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…
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ
FDA Drug · Class II · 2019-11-13 · First Royal Care - 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 (ND…
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hen…
FDA Drug · Class II · 2019-11-13 · Basic Reset - S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-DMSO 100% (PF) STERILE SOLUTION
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICA…
FDA Drug · Class III · 2019-11-13 · Sato Pharmaceutical - S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc
FDA Drug · Class II · 2019-11-13 · Basic Reset - LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045
FDA Drug · Class I · 2019-11-13 · Icu Medical - Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc
FDA Drug · Class II · 2019-11-13 · Basic Reset - Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only,…
FDA Drug · Class III · 2019-11-13 · Lupin Pharmaceuticals - S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
FDA Drug · Class II · 2019-11-13 · Dr Reddy S Laboratories - S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville…
FDA Drug · Class II · 2019-11-13 · Basic Reset - S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX
FDA Drug · Class II · 2019-11-13 · First Royal Care - S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
FDA Drug · Class II · 2019-11-13 · First Royal Care - Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia,…
FDA Drug · Class I · 2019-11-06 · Fitoterapia Usa - Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
FDA Drug · Class II · 2019-11-06 · Innoveix Pharmaceuticals - AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2019-11-06 · Avkare - Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc
FDA Drug · Class III · 2019-11-06 · Arbor Pharmaceuticals - 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 P…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U - Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) a…
FDA Drug · Class II · 2019-11-06 · Glenmark Pharmaceuticals Usa - 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 Ph…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U - Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2019-11-06 · Mylan Pharmaceuticals - Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc
FDA Drug · Class III · 2019-11-06 · Sandoz - Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5…
FDA Drug · Class III · 2019-11-06 · Sandoz - Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc
FDA Drug · Class III · 2019-11-06 · Apotex - Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratorie…
FDA Drug · Class III · 2019-11-06 · Sandoz - Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
FDA Drug · Class II · 2019-11-06 · Innoveix Pharmaceuticals - AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc
FDA Drug · Class II · 2019-11-06 · Avkare - Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
FDA Drug · Class II · 2019-11-06 · Innoveix Pharmaceuticals - Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Can…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U - 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 F…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U - Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, C…
FDA Drug · Class II · 2019-11-06 · Taro Pharmaceuticals U - Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
FDA Drug · Class II · 2019-11-06 · Innoveix Pharmaceuticals - Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India…
FDA Drug · Class III · 2019-11-06 · Auromedics Pharma - PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron…
FDA Drug · Class III · 2019-11-06 · Nephron Pharmaceuticals - Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals - PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals - Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 850…
FDA Drug · Class II · 2019-10-30 · Avella Of Deer Valley Store 38 - PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals - PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals - del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Colu…
FDA Drug · Class II · 2019-10-30 · Nephron Pharmaceuticals - Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Enti…
FDA Drug · Class II · 2019-10-23 · Aurobindo Pharma Usa - Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown,…
FDA Drug · Class III · 2019-10-23 · Kvk Tech - Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Or…
FDA Drug · Class II · 2019-10-23 · Ingenus Pharmaceuticals - Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roor…
FDA Drug · Class II · 2019-10-23 · Jubilant Cadista Pharmaceuticals - Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manuf…
FDA Drug · Class II · 2019-10-23 · Macleods Pharma Usa - Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
FDA Drug · Class II · 2019-10-23 · Spectrum Laboratory Products - Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy,…
FDA Drug · Class II · 2019-10-23 · Atlas Pharmaceuticals - 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 040…
FDA Drug · Class II · 2019-10-16 · Pfizer - Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx…
FDA Drug · Class III · 2019-10-16 · Guerbet - Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103
FDA Drug · Class II · 2019-10-16 · Mylan Laboratories Sterile Products Division - Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Lau…
FDA Drug · Class II · 2019-10-16 · Gcp Laboratories - Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
FDA Drug · Class III · 2019-10-16 · Amneal Pharmaceuticals - DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608
FDA Drug · Class II · 2019-10-16 · Unipharma - Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Inje…
FDA Drug · Class II · 2019-10-16 · Guerbet - DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100…
FDA Drug · Class II · 2019-10-16 · Unipharma - Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc
FDA Drug · Class II · 2019-10-16 · Sandoz - Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc
FDA Drug · Class II · 2019-10-16 · Sandoz - Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01
FDA Drug · Class II · 2019-10-16 · Epic Pharma - Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharm…
FDA Drug · Class II · 2019-10-16 · Morton Grove Pharmaceuticals - Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc
FDA Drug · Class II · 2019-10-16 · Sandoz - Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, I…
FDA Drug · Class III · 2019-10-16 · Teva Pharmaceuticals Usa - Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce…
FDA Drug · Class II · 2019-10-09 · 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)