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
Ascend Laboratories, Llc
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: A...
Oral Drugs·13,560 affected·Mar 14, 2023
High RiskFDA
Hetero Usa Inc
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscata...
Oral Drugs·2,352 affected·Mar 14, 2023
High RiskFDA
Hamilton Medical Ag
HAMILTON-C6, REF: 160021
Medical Devices·103 affected·Mar 14, 2023
High RiskFDA
Advanced Research Medical, Llc
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative ...
Medical Devices·1,150 affected·Mar 14, 2023
RecallFDA
Tippcon Llc
Perrona Hot Sauce Original with Chiltepin Peppers 5 fl oz (148ml) UPC 75 03016 55507 4 packaged in a PET bottle, 12 bottles per case
Food·8,230 affected·Mar 13, 2023
CriticalFDA
Seven Seas International Usa Llc
Biltmore Smoked Sockeye Salmon - 4 oz
Seafood·295 affected·Mar 13, 2023
High RiskFDA
Power Selles Imports Dba Culinary Collective
Matiz Piparra Peppers are packaged in a clear glass jar, net wt. 4lb. (1.8kg), drained wt. 25oz (700g). Product is shelf stable. UPC 832...
Produce·150 affected·Mar 13, 2023
High RiskFDA
Rieckhoff Family Businesses, Inc.
Almost Famous Popcorn Poppy Chow, 9.9 oz bag (UPC 8 5001151513)
Snacks & Candy·2,881 affected·Mar 13, 2023
RecallFDA
Tippcon Llc
Perrona Hot Sauce Black with Chiltepin Peppers Net 5 FL OZ (148 mL) UPC 75 03016 55511 1 packaged in a PET bottle, 12 bottles per case
Food·8,230 affected·Mar 13, 2023
RecallFDA
Tippcon Llc
Perrona Hot Sauce Green with Chiltepin Peppers Net 5 FL OZ (148 mL) UPC 7 503016 555098 packaged in a PET bottle, 12 bottles per case
Food·8,230 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonv...
Oral Drugs·51 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, ...
Drugs·269 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Daws...
Oral Drugs·9 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonv...
Oral Drugs·4 affected·Mar 13, 2023
CriticalFDA
Camber Pharmaceuticals Inc.
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08...
Oral Drugs·1,568 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packa...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Oral Drugs·19 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 6191...
Oral Drugs·90 affected·Mar 13, 2023
High RiskFDA
Direct Rx
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Pack...
Oral Drugs·30 affected·Mar 13, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by N...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by No...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by N...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by No...
Drugs·0 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analy...
Diagnostic Devices·4,895 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a...
Diagnostic Devices·2,001 affected·Mar 10, 2023
High RiskFDA
Howmedica Osteonics Corp.
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Surgical Devices·102 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a ...
Diagnostic Devices·1,148 affected·Mar 10, 2023
High RiskFDA
Alcon Research, Llc
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-...
Surgical Devices·1,035 affected·Mar 10, 2023
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Medical Devices·1,546 affected·Mar 10, 2023
CriticalFDA
Inpeco S.a.
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (AC...
Medical Devices·245 affected·Mar 10, 2023
CriticalFDA
Inpeco S.a.
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP...
Medical Devices·245 affected·Mar 10, 2023
CriticalFDA
Inpeco S.a.
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a360...
Medical Devices·245 affected·Mar 10, 2023
High RiskFDA
20-100 Delicious Seasoning Llc
Sofrito Marinating Sauce, 100% All Natural Ingredients (Caribbean Seasoning), Net Wt 16 oz. (460g), 8 oz. (230g) and 32(920g) oz. Glass J...
Food·8 affected·Mar 9, 2023
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, ...
Oral Drugs·69,375 affected·Mar 9, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/1...
Oral Drugs·1,920 affected·Mar 9, 2023
High RiskFDA
Philips North America Llc
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Diagnostic Devices·10 affected·Mar 9, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Diagnostic Devices·10 affected·Mar 9, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Ve...
Diagnostic Devices·256 affected·Mar 9, 2023
High RiskFDA
Devilbiss Healthcare Llc
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Respiratory Devices·143,397 affected·Mar 9, 2023
RecallFDA
Pfizer Inc.
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfize...
Oral Drugs·1,926 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Medical Devices·32 affected·Mar 8, 2023
High RiskFDA
Radiometer Medical Aps
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devic...
Medical Devices·1,806 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Medical Devices·44 affected·Mar 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Medical Devices·900 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Medical Devices·50 affected·Mar 8, 2023