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
Pom Medical Llc
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med ...
Respiratory Devices·5,610 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Product...
Diagnostic Devices·128,196 affected·Jul 11, 2018
CriticalFDA
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This...
Respiratory Devices·328 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitr...
Diagnostic Devices·627,543 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products ...
Diagnostic Devices·420,105 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Apogee Foods
Thunderbird Bars 1.15 oz Apple Pie Kid Bar (carton of 120)
Food·57 affected·Jul 10, 2018
High RiskFDA
Apogee Foods
Thunderbird Bars 1.7 oz Pecan Goji Pistachio Bar (case of 120)
Food·63 affected·Jul 10, 2018
High RiskFDA
Lenni's Crab Mix, Inc
Lenny's Maryland Crab Mix
Seafood·408 affected·Jul 10, 2018
RecallFDA
Valeant Pharmaceuticals North America Llc
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instru...
Topical Drugs·306 affected·Jul 10, 2018
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·5,507 affected·Jul 10, 2018
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·7,024 affected·Jul 10, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 265...
Oral Drugs·28,436 affected·Jul 9, 2018
High RiskFDA
Sorin Crm Sas
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Medical Implants·16 affected·Jul 9, 2018
High RiskFDA
Merit Medical Systems, Inc.
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non...
Medical Devices·6 affected·Jul 9, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusio...
Medical Devices·47 affected·Jul 9, 2018
High RiskFDA
Sorin Crm Sas
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Medical Implants·10 affected·Jul 9, 2018
High RiskFDA
Earthrise Nutritionals Llc
Earthrise Natural Spirulina; Net Weight: 20.0 kg( 44.0 lbs); Double bag sealed - 1 bag per box. UPC: 0 32602 99040 3
Food·1,014 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. P...
Respiratory Devices·3,000 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Prod...
Respiratory Devices·12,000 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 21...
Respiratory Devices·850 affected·Jul 6, 2018
High RiskFDA
3m Company - Health Care Business
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish ...
Medical Devices·73 affected·Jul 6, 2018
High RiskFDA
Neotract Inc
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By:...
Medical Devices·8,804 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product ...
Respiratory Devices·2,550 affected·Jul 6, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING POMEGRANETE JUICE DRNK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING MANDARIN JUICE DRINK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Ywam Faith Harvest Helpers
Canned Salmon in unlabeled 8oz metal cans. Cans are packaged into a case of 92 cans. The case label is read: "Canned Salmon***Product ...
Seafood·4,818 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING GRAPEFRUIT JUICE DRINK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING SOUR CHERRY JUICE DRINK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING LEMON JUICE DRINK , 6 /34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING LIME JUICE DRINK, 6/34 oz, glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
The Hain Celestial Group, Inc. - Worldwide Hq
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per ...
Drugs·47,128 affected·Jul 5, 2018
High RiskFDA
Sanofi-aventis U.s. Llc
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Phy...
Injectable Drugs·3,214 affected·Jul 5, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake Ci...
Topical Drugs·27,803 affected·Jul 5, 2018
High RiskFDA
Ctl Medical Corporation
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Medical Devices·133 affected·Jul 5, 2018
CriticalFDA
Pro-med Instruments Gmbh
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Medical Devices·31 affected·Jul 5, 2018
RecallFDA
Byrd Cookie Co
PINK LEMONADE COOKIES Byrd's FAMOUS COOKIES; NET WT. 7 OZ .(198g) BOX; BYRD COOKIE COMPANY 6700 WATERS SAVANNAH, GA 31406 800-291-2973; U...
Bakery & Grains·20,778 affected·Jul 3, 2018
High RiskFDA
Medgyn Products, Inc.
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: M...
Drugs·2,750 affected·Jul 3, 2018
High RiskFDA
Medi-fare Drug And Home Health Center
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West...
Injectable Drugs·1,116 affected·Jul 3, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutica...
Oral Drugs·2,508 affected·Jul 3, 2018
High RiskFDA
Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Medical Devices·2,131 affected·Jul 3, 2018
RecallFDA
Alden Optical
Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenle...
Medical Devices·36 affected·Jul 3, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by ...
Medical Devices·23 affected·Jul 3, 2018
High RiskFDA
Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage:...
Surgical Devices·166 affected·Jul 3, 2018
High RiskFDA
Convatec, Inc
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile...
Surgical Devices·3,881 affected·Jul 3, 2018
High RiskFDA
Abbott Vascular
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with intervention...
Medical Implants·26 affected·Jul 3, 2018