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
National Fish & Seafood, Inc.
SCHOONER PRE-COOKED CRUNCHY FLOUNDER FILLETS 12/16 OZ
Food·177 affected·Jun 8, 2017
High RiskFDA
Phillips Co.
TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, ...
Topical Drugs·200 affected·Jun 8, 2017
High RiskFDA
Phillips Co.
StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-10...
Drugs·10 affected·Jun 8, 2017
High RiskFDA
Phillips Co.
VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
Drugs·20 affected·Jun 8, 2017
High RiskFDA
Phillips Co.
StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 0...
Drugs·20 affected·Jun 8, 2017
High RiskFDA
Phillips Co.
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Co...
Topical Drugs·100 affected·Jun 8, 2017
High RiskFDA
Phillips Co.
Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company,...
Topical Drugs·100 affected·Jun 8, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 /...
Diabetes Devices·1,134 affected·Jun 8, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN nu...
Diabetes Devices·67,040 affected·Jun 8, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Almond Yogurt, Peach, NET WT. 5.3 oz (150G) Case UPC: 8-56624-00415-9 Distributed by Lyrical Foods, Hayward, CA.
Dairy·1,878 affected·Jun 7, 2017
High RiskFDA
Oxford Frozen Foods Plant 1
1/2" Thick Cut Beer Battered Onion Rings: ALE HOUSE BEER BATTERED STEAK CUT ONION RINGS NET WT. 10 lb (4.45 kg) - 33074
Produce·36,983 affected·Jun 7, 2017
High RiskFDA
Slade Gorton & Company, Inc.
Gourmet Bay - Toasted Crumb Breaded Tilapia, 5-7 oz. (Bulk 5 lbs container) refrigerated Product Code: 7396701
Bakery & Grains·0 affected·Jun 7, 2017
High RiskFDA
Oxford Frozen Foods Plant 1
Small White Button Mushroom Regular Batter: ATLANTIC GOLD Battered Mushrooms Net Weight 5 lb (2.27 kg) - 34086; Atlantic Gold Battered Mu...
Food·36,983 affected·Jun 7, 2017
High RiskFDA
Oxford Frozen Foods Plant 1
5/8" Thick Cut Beer Battered Onion Rings: ALE HOUSE BEER BATTERED STEAK CUT ONION RINGS NET WT. 4/2.5 lb 10 lb (4.45 kg) - 33223; OXFORD ...
Produce·0 affected·Jun 7, 2017
High RiskFDA
Wicks
Code: LM290; Keep Frozen; Lucky's Maryland Style Crab Cakes: Net Wt. 13.5 lbs; 72-3OZ; packed for Lucky's Markets, Niwot, CO 80503; ...
Seafood·240 affected·Jun 7, 2017
High RiskFDA
Wicks
Code: 425FS; Keep Frozen; Gourmet Salmon Burgers; Net Wt. 6.40 lbs, 24-4.25 OZ patties; Wick's Kitchens, Trainer, PA 19061; Lot # ...
Seafood·812 affected·Jun 7, 2017
High RiskFDA
Joseph Shalhoub & Son, Inc.
joray fruit roll  FRUIT PUNCH flavor NET WT 1 OZ. (28g). UPC# 0 51063 50009 9.
Produce·1,200 affected·Jun 7, 2017
High RiskFDA
Meduri Farms Inc
Meduri Farms Dried Strawberries/Sugar Infused, Catalog # 010282. Dried Strawberries sugar infused packaged in a 10, 20 or 25 lbs. corr...
Produce·2,880 affected·Jun 7, 2017
High RiskFDA
Slade Gorton & Company, Inc.
Gourmet Bay - Citrus Coconut Breaded Tilapia, 5-7 oz (Bulk 5 lbs) refrigerated Product Code: 7322401
Bakery & Grains·19,773 affected·Jun 7, 2017
High RiskFDA
Sea Watch International Ltd
Sea Watch Brand Beer Battered Clam Strips Pack Size: 24/4 oz. bags/case
Food·4,527 affected·Jun 7, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Almond Yogurt, Strawberry ,NET WT. 5.3 oz (150G) ; Case UPC: 8-56624-00414-2 Distributed by Lyrical Foods, Hayward, CA.
Dairy·2,137 affected·Jun 7, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Almond Yogurt, Pineapple, NET WT. 5.3 oz (150G) Case UPC: 8-56624-00435-7 Distributed by Lyrical Foods, Hayward, CA.
Dairy·469 affected·Jun 7, 2017
High RiskFDA
Oxford Frozen Foods Plant 1
33034 33116 Thick Cut Regular Batter: ATLANTIC GOLD STEAK CUT BATTERED ONION RINGS NET WT 10 lb (4.54 kg) - 33166
Produce·36,983 affected·Jun 7, 2017
High RiskFDA
Wicks
WICK'S (4) Oven-Ready; Southern Style Shrimp Cakes; Net Weight 10 OZ; 4 - 2.5 OZ Cakes; Distributed by: Wick's Kitchens, Trainer, PA 1906...
Seafood·494 affected·Jun 7, 2017
High RiskFDA
Oxford Frozen Foods Plant 1
Thin Cut Regular Batter: BLUE ACRES BATTERED ONION RINGS, NET WT. 10 lb (4.54 kg) - 33049; ATLANTIC GOLD BATTERED ONION RINGS NET WT. 4/...
Produce·36,983 affected·Jun 7, 2017
High RiskFDA
Amodio's, Inc.
Amodio's Toasted Coconut Panko sold in an 8 oz bags packaged in cases of 8.
Food·157 affected·Jun 7, 2017
High RiskFDA
Oxford Frozen Foods Plant 1
ALE HOUSE BEER BATTERED 3/8 ONION RINGS - NET WT. 4/2.5 lb (1.13 kg) 10 lb (4.54 kg) - 33221
Produce·36,983 affected·Jun 7, 2017
High RiskFDA
Sea Watch International Ltd
Sailors Choice Brand Breaded Clam Strips Pack Size: 24/4 oz. bags/case
Bakery & Grains·1,705 affected·Jun 7, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Almond Yogurt, Blueberry , NET WT. 5.3 oz (150G) Case UPC: 8-56624-00413-5 Distributed by Lyrical Foods, Hayward, CA.
Dairy·1,606 affected·Jun 7, 2017
High RiskFDA
Slade Gorton & Company, Inc.
Gourmet Bay - Honey Mustard Breaded Tilapia, 5-7 oz.. refrigerated (Bulk 5 lbs container) Product Code: 7324801
Bakery & Grains·19,773 affected·Jun 7, 2017
High RiskFDA
Sea Watch International Ltd
Sea Watch Beer Battered Clam Strips Pack Size: 2/3 lb. bags/case
Food·1,154 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to pro...
Medical Devices·64 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended ...
Medical Devices·145 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
CriticalFDA
Cenorin, Llc
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
Medical Devices·43 affected·Jun 7, 2017
High RiskFDA
Mako Surgical Corporation
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial bou...
Medical Devices·20 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-se...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1...
Surgical Devices·214 affected·Jun 7, 2017