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
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68,659 recalls
High RiskFDA
Philips North America
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Medical Devices·119 affected·Jan 3, 2024
CriticalFDA
Thoratec Corp.
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch C...
Cardiac Devices·1,560 affected·Jan 3, 2024
High RiskFDA
Tornier, Inc
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Medical Devices·50 affected·Jan 3, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical i...
Medical Devices·13 affected·Jan 3, 2024
High RiskFDA
Philips North America
Achieva XR. Model (REF) Numbers 781153, 781253.
Medical Devices·23 affected·Jan 3, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Diagnostic Devices·61 affected·Jan 3, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Medical Devices·8 affected·Jan 3, 2024
High RiskFDA
Philips North America
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Medical Devices·23 affected·Jan 3, 2024
High RiskFDA
United Orthopedic Corporation
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE251511...
Medical Devices·0 affected·Jan 3, 2024
High RiskFDA
Stonewall Kitchen, Llc
Vermont Village Unsweetened Apple Sauce (24oz)
Food·9,027 affected·Jan 2, 2024
High RiskFDA
Kinjin Food Private Limited
Vandevi Compounded Asafoetida 50 gm, 100 gms 200 gm, 500 gm, 1 kg. Packaged in yellow plastic bottles with plastic shrink wrap blue/yello...
Food·18,580 affected·Jan 2, 2024
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-...
Oral Drugs·38,952 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affec...
Medical Devices·1,993 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affe...
Medical Devices·1,993 affected·Jan 2, 2024
High RiskFDA
Zimmer Surgical Inc
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Medical Devices·76 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affec...
Medical Devices·13 affected·Jan 2, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affe...
Medical Devices·13 affected·Jan 2, 2024
CriticalFDA
Mead Johnson & Company Llc
Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8 OZ). UPC Code of 300871239418 or 300871239456 an...
Baby Food & Formula·1,396,438 affected·Dec 30, 2023
CriticalFDA
Samsung Bean Sprout
Soy Bean Sprouts in a package labeled in part: Sam Sung Soy Bean Sprouts, Net Wt. 1LB have a Sell By date of December 21, 2023.
Food·500 affected·Dec 29, 2023
RecallFDA
Richelieu Foods, Inc.
365 Whole Foods Vegan Ultimate Veggie, Thin Cust Pizza. Item # 999209512 Topped with Vegan Mozzarella-Style Cheese, Green and Red Bell ...
Dairy·183 affected·Dec 29, 2023
CriticalFDA
Ocean Group Inc.
201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA ...
Seafood·166 affected·Dec 29, 2023
CriticalFDA
Ocean Group Inc.
202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FA...
Seafood·18,042 affected·Dec 29, 2023
High RiskFDA
Ascend Laboratories, Llc
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs·3,288 affected·Dec 29, 2023
High RiskFDA
Strides Pharma Inc.
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distrib...
Oral Drugs·396 affected·Dec 29, 2023
High RiskFDA
Rising Pharma Holding, Inc.
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, In...
Oral Drugs·47,976 affected·Dec 29, 2023
CriticalFDA
Datex-ohmeda, Inc.
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Medical Devices·12 affected·Dec 29, 2023
High RiskFDA
Aesculap Inc
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Medical Devices·60 affected·Dec 29, 2023
RecallFDA
Philips North America
Achieva 3.0T, Model No. 781177
Medical Devices·7 affected·Dec 29, 2023
RecallFDA
Philips North America
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Medical Devices·7 affected·Dec 29, 2023
High RiskFDA
Aesculap Inc
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Medical Devices·53 affected·Dec 29, 2023
RecallFDA
Philips North America
Intera 1.5T, Model No. 781195
Medical Devices·7 affected·Dec 29, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, C...
Injectable Drugs·10,152 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd En...
Injectable Drugs·8,976 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO...
Injectable Drugs·7,548 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd En...
Injectable Drugs·13,920 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewoo...
Injectable Drugs·29,016 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) ...
Inhaled / Nasal Drugs·7,992 affected·Dec 28, 2023
CriticalFDA
Denver Solutions, Llc Dba Leiters Health
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewo...
Injectable Drugs·12,564 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed...
Inhaled / Nasal Drugs·7,992 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bott...
Inhaled / Nasal Drugs·8,160 affected·Dec 28, 2023
High RiskFDA
Seaway Pharma Inc.
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle...
Drugs·4,176 affected·Dec 28, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Walt...
Drugs·69,590 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
Medical Devices·223,056 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Medical Devices·20,186 affected·Dec 28, 2023
High RiskFDA
Maquet Medical Systems Usa
Bubble Sensor (REF: 70105.5720)
Medical Devices·274 affected·Dec 28, 2023