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
Universal Meditech Inc.
One Step Pregnancy Test REF 100-01
Medical Devices·147,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
Diagnostic Devices·122,500 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Medical Devices·2,400 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
Medical Devices·25,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS One Step LH Ovulation Test Strip REF 200-07
Medical Devices·525 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
Medical Devices·1,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
HealthyWiser UriTest" UTI Test Strips REF 900-UTI
Medical Devices·5,960 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
Medical Devices·5,025 affected·May 22, 2023
CriticalFDA
Aquamar Inc
Miyako Select Shredded Crab Meat Keep Refrigerated #1485 Ingredients: Fish Protein (Pollock, Threadfin Bream and/or Flying Fish), Water, ...
Meat & Poultry·31,079 affected·May 19, 2023
High RiskFDA
Procaps S.a. De C.v.
Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardbo...
Supplements·33,684 affected·May 19, 2023
CriticalFDA
Aquamar Inc
Kanimi Crab Flavored Seafood Fancy Shred Style 92410 Ingredients: Fish Protein (Pollock, Whiting and or Threadfin Bream), Water, Potato S...
Seafood·31,079 affected·May 19, 2023
CriticalFDA
Aquamar Inc
Kanimi Easy Roll Crab Flavored Seafood Shred Style 91406 VCM Ingredients: Fish Protein (Pollock Whiting and or Threadfin Bream), Water, P...
Seafood·31,079 affected·May 19, 2023
CriticalFDA
Olam Food Ingredients
Onion Powder Premium, 44.9 and 50 lb. fiber bags sold as bulk ingredient
Produce·42,764 affected·May 19, 2023
CriticalFDA
Meijer Inc
Frederik's by Meijer Dark Chocolate Almonds, 12oz stand-up pouch, UPC 7-08820-68730-1
Snacks & Candy·81,042 affected·May 19, 2023
CriticalFDA
Meijer Inc
Meijer Express Dark Chocolate Covered Almonds, 7.5oz plastic cup with lid, UPC 7-60236-19787-4
Snacks & Candy·9,030 affected·May 19, 2023
High RiskFDA
Springworks Farm Inc.
Springworks Organic single cut green leaf lettuce, 4 oz.
Produce·148 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 2...
Injectable Drugs·370,200 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Injectable Drugs·2,249,980 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Injectable Drugs·2,249,980 affected·May 19, 2023
High RiskFDA
Zimmer, Inc.
NexGen Precoat Stemmed Tibial Plate Size 5
Medical Devices·0 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Medical Devices·2,097 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Medical Devices·36,337 affected·May 19, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients s...
Respiratory Devices·386 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Medical Devices·237 affected·May 19, 2023
CriticalFDA
Arrow International Inc.
ARROW Endurance Extended Dwell Peripheral Catheter System
Surgical Devices·262,016 affected·May 19, 2023
High RiskFDA
Baxter Healthcare Corporation
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Medical Devices·7 affected·May 19, 2023
High RiskFDA
Baxter Healthcare Corporation
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Medical Devices·8 affected·May 19, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing n...
Respiratory Devices·4,155 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Medical Devices·2,707 affected·May 19, 2023
High RiskFDA
Ascensia Diabetes Care Us, Inc.
Contour¿ next GEN Blood Glucose Monitoring System
Diabetes Devices·2,888 affected·May 19, 2023
High RiskFDA
Fire Distributors Plus Llc
EARTH KRATOM TRAINWRECK 150 CAPSULES (UPC: 908193737324) (50 UNITS/CASE) and 300 CAPSULES (UPC: 005821990011) (25 UNITS/CASE). DISTRIBUTE...
Beverages·26,500 affected·May 18, 2023
High RiskFDA
Fire Distributors Plus Llc
EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES (UPC: 212223242796) (100 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna ...
Beverages·31,600 affected·May 18, 2023
High RiskFDA
Werner Gourmet Meat Snacks, Inc.
Chili Cacahuate Japones, net weight 5 oz (127g), packaged in a soft teal colored plastic pouch with the UPC code 7 09972 80082 2. There ...
Dairy·2,149 affected·May 18, 2023
RecallFDA
Aurolife Pharma, Llc
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13...
Oral Drugs·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) END...
Surgical Devices·4,644 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; ...
Surgical Devices·770,147 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-...
Cardiac Devices·172,722 affected·May 18, 2023
RecallFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration rang...
Diagnostic Devices·2 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA ...
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI45...
Surgical Devices·620 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTA...
Medical Devices·4,500 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) ...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Medical Devices·128 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Medical Devices·144 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Medical Devices·183,240 affected·May 18, 2023