Source
FDA Recalls
The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.
68,659Total Recalls
www.fda.gov →Official Site
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How to report to FDA →68,659 recalls
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply
Oral Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply
Oral Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;
Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply
Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply
Oral Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Oral Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply
Oral Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Drugs0 affectedApr 3, 2018
High RiskFDA
Kroger Specialty Pharmacy, Inc.
Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98
Drugs0 affectedApr 3, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for i...
Diagnostic Devices35 affectedApr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion ...
Medical Devices444 affectedApr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion...
Medical Devices444 affectedApr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion P...
Medical Devices444 affectedApr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion ...
Medical Devices444 affectedApr 3, 2018
High RiskFDA
Diamond Wipes International, Inc.
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 666...
Drugs5,148,792 affectedApr 2, 2018
High RiskFDA
Diamond Wipes International, Inc.
ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Laud...
Drugs51,840 affectedApr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Medical Devices235 affectedApr 2, 2018
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Medical Devices16 affectedApr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Medical Devices196 affectedApr 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device ...
Medical Implants30 affectedApr 2, 2018
High RiskFDA
Aesdex
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal An...
Medical Devices400 affectedApr 2, 2018
CriticalFDA
Club 13 Enterprises Warehouse
Club 13 Kratom Maeng Da Red XS capsules; 5, 20, 25, 40, 50 capsule bottles
Food873 affectedMar 31, 2018
CriticalFDA
Club 13 Enterprises Warehouse
Club 13 Kratom Maeng Da Red capsules; 5, 25, 50, 100, 120 capsule bottles, and Club 13 Kratom Maeng Da Red capsules in bulk bags.
Food7,683 affectedMar 31, 2018
CriticalFDA
Club 13 Enterprises Warehouse
Club 13 Kratom Maeng Da Red powder; Pouches of 15, 30, 90, 150, 454 grams, and Club 13 Kratom Maeng Da Red powder in bulk bags.
Food10,237 affectedMar 31, 2018
High RiskFDA
Advocare International, Lp
AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product code, P3221
Supplements15,640 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Cali Thai Kratom all packages, all quantities
Food1,500 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Pain Out Maeng Da Kratom all packages, all quantities
Food2,487 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Pain Out Green Malay Kratom all packages, all quantities
Food1,340 affectedMar 30, 2018
RecallFDA
Funky Chunky Llc
funky chunky Chocolate Pretzels. Pretzels, Caramel, Chocolate, Pecans. Sold in the following packaging configurations: 1. Small Bag...
Dairy172 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Nirvanio Green Malay Kratom all packages, all quantities
Food3,341 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Nirvanio Bali Kratom all packages, all quantities
Food0 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Nirvanio Maeng Da Kratom all packages, all quantities
Food5,517 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Cali Green Malay Kratom all packages, all quantities
Food1,500 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Nirvanio Special Reserve Kratom all packages, all quantities
Food4,624 affectedMar 30, 2018
High RiskFDA
Advocare International, Lp
AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement Product code, P3201
Supplements48,176 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Cali Maeng Da Kratom all packages, all quantities
Food3,000 affectedMar 30, 2018
CriticalFDA
Nutrizone Llc
Pain Out Thai Kratom all packages, all quantities
Food851 affectedMar 30, 2018
High RiskFDA
Avkare Inc.
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 502...
Oral Drugs2,135 affectedMar 30, 2018
High RiskFDA
Marcas Usa Llc
PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60
Topical Drugs69,238 affectedMar 30, 2018
High RiskFDA
Think Surgical, Inc.
Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is us...
Surgical Devices951 affectedMar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and rev...
Medical Devices0 affectedMar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Medical Devices2 affectedMar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Medical Devices20 affectedMar 30, 2018
High RiskFDA
Immuno-mycologics, Inc
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatograp...
Diagnostic Devices875 affectedMar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and re...
Medical Devices16 affectedMar 30, 2018