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

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Karl Storz Endoscopy
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethrosco...
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Ma...
Oral Drugs·1,247,067 affected·Mar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manu...
Oral Drugs·1,466,150 affected·Mar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC...
Oral Drugs·2,361,924 affected·Mar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# ...
Oral Drugs·303,696 affected·Mar 31, 2022
High RiskFDA
Merck Sharp & Dohme Corp
Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, R...
Oral Drugs·3,600 affected·Mar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manu...
Oral Drugs·657,336 affected·Mar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC#...
Oral Drugs·1,214,016 affected·Mar 31, 2022
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedure...
Surgical Devices·73 affected·Mar 31, 2022
High RiskFDA
Coopersurgical, Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography proced...
Surgical Devices·169 affected·Mar 31, 2022
High RiskFDA
Coopersurgical, Inc.
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingograph...
Surgical Devices·90 affected·Mar 31, 2022
High RiskFDA
Olympus Corporation Of The Americas
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Surgical Devices·1,386 affected·Mar 31, 2022
High RiskFDA
Skippy Foods, Llc.
SKIPPY Creamy Peanut Butter Blended with Plant Protein NET WT 14 (397 g) UPC 037600880954 packaged in clear plastic jar with black label
Dairy·9,353 affected·Mar 30, 2022
High RiskFDA
Skippy Foods, Llc.
SKIPPY Reduced Fat Chunky Peanut Butter NET WT 16.3 oz (1 LB 3 OZ) 462 g UPC 037600104999 packaged in clear plastic jar with blue label
Dairy·9,353 affected·Mar 30, 2022
High RiskFDA
Skippy Foods, Llc.
SKIPPY Reduced Fat Creamy Peanut Butter NET WT 40 oz (2 LB 8 OZ) 1.13 kg UPC 037600105200 packaged in clear plastic jar with blue label.;...
Dairy·9,353 affected·Mar 30, 2022
CriticalFDA
Unilever United States Inc.
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 7515...
Drugs·0 affected·Mar 30, 2022
High RiskFDA
Unilever United States Inc.
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By U...
Drugs·0 affected·Mar 30, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI techno...
Medical Implants·1,021 affected·Mar 30, 2022
High RiskFDA
Restor3d Inc.
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Surgical Devices·4 affected·Mar 30, 2022
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number...
Medical Devices·22 affected·Mar 30, 2022
High RiskFDA
Medtronic Neuromodulation
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Medical Implants·1 affected·Mar 30, 2022
High RiskFDA
Invacare Corporation
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Medical Devices·133 affected·Mar 30, 2022
High RiskFDA
Devicor Medical Products Inc
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Medical Devices·90 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Cardiac Devices·667 affected·Mar 30, 2022
High RiskFDA
Medtronic Neuromodulation
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Medical Implants·14,164 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Cardiac Devices·0 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Cardiac Devices·510 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Cardiac Devices·59 affected·Mar 30, 2022
High RiskFDA
Restor3d Inc.
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual...
Surgical Devices·14 affected·Mar 30, 2022
High RiskFDA
Restor3d Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Surgical Devices·9 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ Sys...
Cardiac Devices·645 affected·Mar 30, 2022
CriticalFDA
Giant Eagle, Inc.
Giant Eagle, Happy Face Cookie 4 Pack 25051900000, 11 oz, Clam Shell
Bakery & Grains·41 affected·Mar 29, 2022
CriticalFDA
Pink Toyz
Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311...
Oral Drugs·120 affected·Mar 29, 2022
RecallFDA
Aptapharma Inc.
Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 6...
Drugs·40,000 affected·Mar 29, 2022
CriticalFDA
Teva Pharmaceuticals Usa Inc
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, In...
Injectable Drugs·1,565 affected·Mar 29, 2022
CriticalFDA
Best Brands Consumer Products, Inc.
Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company...
Drugs·44,640 affected·Mar 29, 2022
CriticalFDA
Best Brands Consumer Products, Inc.
The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Com...
Drugs·346,320 affected·Mar 29, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
Medical Devices·21,757 affected·Mar 29, 2022
High RiskFDA
Philips North America Llc
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images...
Medical Devices·330 affected·Mar 29, 2022
CriticalFDA
Groundwork Coffee Llc
groundwork MIND-FULL Bar. Ingredients: Gluten-free oats, Flax seed, Chocolate chips, Brown sugar, Chia seeds, peanut butter, salt, cinna...
Dairy·0 affected·Mar 28, 2022
High RiskFDA
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bo...
Oral Drugs·791 affected·Mar 28, 2022
High RiskFDA
Stryker Gmbh
Smart Toe II Intramedullary Arthrodesis Implant
Medical Implants·246 affected·Mar 28, 2022
High RiskFDA
Caire, Inc.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Respiratory Devices·2 affected·Mar 25, 2022
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa li...
Diagnostic Devices·199 affected·Mar 25, 2022
High RiskFDA
Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
Medical Devices·300 affected·Mar 25, 2022
CriticalFDA
Medtronic Formerly Covidien
Puritan Bennett 980 Series Ventilator
Respiratory Devices·18,508 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Diagnostic Devices·1,575 affected·Mar 25, 2022