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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68,659 recalls
High RiskFDA
Accord Healthcare, Inc.
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Ac...
Injectable Drugs·48,089 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int...
Oral Drugs·104,945 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 1...
Oral Drugs·1,394,208 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durh...
Injectable Drugs·37,691 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-3...
Injectable Drugs·228,760 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose v...
Injectable Drugs·65,233 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcar...
Injectable Drugs·322 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16...
Oral Drugs·256,648 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 1...
Oral Drugs·205,631 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle ND...
Oral Drugs·291,378 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 1...
Oral Drugs·613,553 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414...
Oral Drugs·69,122 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 1...
Oral Drugs·102,360 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16...
Oral Drugs·241,585 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC...
Oral Drugs·747,464 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthc...
Injectable Drugs·5,273 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16...
Oral Drugs·992,622 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottl...
Oral Drugs·56,862 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle...
Oral Drugs·63,247 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufac...
Oral Drugs·10,992 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, ND...
Oral Drugs·170,448 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufacture...
Oral Drugs·113,003 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufact...
Oral Drugs·37,790 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa...
Oral Drugs·821 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, ...
Injectable Drugs·5,090 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 1...
Oral Drugs·1,420,988 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 1672...
Oral Drugs·1,113,264 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003...
Oral Drugs·1,158,839 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC...
Injectable Drugs·23,814 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-...
Oral Drugs·88,728 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Inta...
Oral Drugs·8,184 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16...
Oral Drugs·2,731,365 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 1...
Oral Drugs·1,109,904 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16...
Oral Drugs·75,190 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: I...
Oral Drugs·181,848 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 167...
Oral Drugs·325,356 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottl...
Oral Drugs·9,600 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured ...
Oral Drugs·32,688 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·317 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Medical Devices·8,909 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·36,875 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0...
Medical Devices·11,792 affected·Feb 7, 2023
High RiskFDA
Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Medical Devices·47 affected·Feb 7, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 099...
Medical Devices·4,793 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemo...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·200 affected·Feb 7, 2023
High RiskFDA
Labories Medical Technologies
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Medical Devices·415,480 affected·Feb 7, 2023