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
CriticalFDA
3fish Inc.
Carolina Style Crab Cakes (Frozen), 2 x 8ct  INGLES, Net Wt 4 lbs, Packed by 3fish, Inc.
Seafood·314 affected·Sep 7, 2012
High RiskFDA
Zimmer, Inc.
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the appli...
Medical Devices·60 affected·Sep 7, 2012
CriticalFDA
Baxter Healthcare Corp.
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile...
Medical Devices·488,504 affected·Sep 7, 2012
High RiskFDA
C.r. Bard, Inc., Urological Division
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated...
Surgical Devices·4,032 affected·Sep 7, 2012
High RiskFDA
Optovue Inc.
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped w...
Medical Devices·795 affected·Sep 7, 2012
CriticalFDA
Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV f...
Medical Devices·1,995,040 affected·Sep 7, 2012
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation d...
Medical Devices·757 affected·Sep 7, 2012
High RiskFDA
Lehi Valley Trading Co.
Licorice Sticks sold under the following brand names: 1) Orange Patch Country Store Licorice Sticks, New Wt, 12 oz. Packaged in plastic...
Meat & Poultry·0 affected·Sep 6, 2012
CriticalFDA
Eco Health, Inc.
florAlign Prebiotic Formula, sizes: 90g, 180g, 270g
Baby Food & Formula·274 affected·Sep 6, 2012
CriticalFDA
Gills Onions, Llc
3/16" Slivered Red Onions, 1/5 lb; 1/4" Slivered Red Onions, 2/5lb, 4/5lb;
Produce·115 affected·Sep 6, 2012
CriticalFDA
Gills Onions, Llc
1/4" Diced Red Onions, 5lb, 2/5lb, 4/5lb; 3/8" Diced Red Onions, 2/5 lb, 4/5lb;
Produce·0 affected·Sep 6, 2012
CriticalFDA
Gills Onions, Llc
1/4" Slivered Yellow Onions, 2/5lb, 4/5lb. 1/8" Slivered Yellow Onions, 2/5lb, 4/5lb. 3/16" Slivered Yellow Onions, 2/5lb, 5/2lb, ...
Produce·0 affected·Sep 6, 2012
High RiskFDA
Church & Dwight Inc
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ ...
Drugs·42,768 affected·Sep 6, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 7...
Diagnostic Devices·93 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone ...
Medical Devices·314 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to b...
Medical Devices·94 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach sof...
Medical Devices·39,362 affected·Sep 6, 2012
RecallFDA
Gynex Corporation
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. L...
Surgical Devices·19 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to b...
Medical Devices·400 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ...
Medical Devices·7 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone...
Medical Devices·0 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach sof...
Medical Devices·4,321 affected·Sep 6, 2012
High RiskFDA
Greatbatch Medical
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientifi...
Cardiac Devices·787 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repai...
Medical Devices·66 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone ...
Medical Devices·1,315 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone ...
Medical Devices·372 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ...
Medical Devices·7 affected·Sep 6, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone...
Medical Devices·0 affected·Sep 6, 2012
High RiskFDA
F. Hoffmann-laroche Ltd.
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, W...
Drugs·42,010 affected·Sep 5, 2012
High RiskFDA
The Anspach Effort, Inc.
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed f...
Medical Devices·8 affected·Sep 5, 2012
High RiskFDA
Wright Medical Technology Inc
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Num...
Medical Devices·729 affected·Sep 5, 2012
High RiskFDA
Wright Medical Technology Inc
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X...
Medical Devices·840 affected·Sep 5, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per b...
Oral Drugs·1,440 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 ca...
Oral Drugs·2,988 affected·Sep 4, 2012
RecallFDA
Apace Ky Llc
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Oral Drugs·81,516 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b...
Oral Drugs·56,808 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mar...
Oral Drugs·183,141 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: B...
Oral Drugs·3,552 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules...
Oral Drugs·7,608 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by...
Oral Drugs·2,160 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonso...
Oral Drugs·16,848 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-1...
Oral Drugs·17,136 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL...
Oral Drugs·96 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Dis...
Oral Drugs·48,120 affected·Sep 4, 2012
High RiskFDA
Raritan Pharmaceuticals, Inc.
Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bo...
Oral Drugs·46,104 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
Medical Devices·1,406 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
NCB¿ screw ¿ 4.0 self-tapping
Medical Devices·41 affected·Sep 4, 2012
High RiskFDA
Zimmer, Inc.
DTO" Implant
Medical Implants·0 affected·Sep 4, 2012