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
Pharmedium Services, Llc
Midazolam HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Nicardipine HCl in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging.
Drugs·0 affected·Dec 27, 2017
High RiskFDA
Pharmedium Services, Llc
Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
Injectable Drugs·0 affected·Dec 27, 2017
High RiskFDA
Little Rapids Corporation
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Medical Devices·153 affected·Dec 27, 2017
High RiskFDA
Ormco/sybronendo
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intende...
Medical Devices·25,765 affected·Dec 27, 2017
High RiskFDA
Mako Surgical Corporation
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA),...
Surgical Devices·736 affected·Dec 27, 2017
High RiskFDA
Ajc International, Inc.
Early Dawn; Whole Tilapia IQF, Gutted & Scaled, Farm Raised, 40 lbs.; Size 550-750g OR 750g+, Lot No.: 1985507; Production Date: 08/12/20...
Food·169 affected·Dec 22, 2017
CriticalFDA
Daisy's Bakery Inc.
Daisy s Bakery Inc., Gourmet Concha, 4 oz. / 1 per package, Plastic Bag, 12 units per case
Food·590 affected·Dec 22, 2017
CriticalFDA
Nodine's Smokehouse Inc.
Smoked salmon in 1.5 oz. and 8 oz. packages
Seafood·8 affected·Dec 22, 2017
CriticalFDA
Bellisio Foods Inc
Michelina's Fettuccine Alfredo NET WT. 8.5 oz package Frozen CONTAINS MILK, WHEAT BELLISIO FOODS, INC., DULUTH, MN 55802 UPC 7 17854 10501 9
Dairy·455 affected·Dec 22, 2017
High RiskFDA
Harris Teeter Distribution Ctr
Harris Teeter's HT Traders Mama Biscotti Mini Biscotti, Triple Chocolate, UPC: 7203670827.
Snacks & Candy·80 affected·Dec 22, 2017
High RiskFDA
Coconuthead, Llc
CO YO Coconut Yogurt Alternative CHOCOLATE, 5.3 oz and 12 oz. plastic container, 6 packages per case. Store between 36 and 42 F. Manufa...
Dairy·2,712 affected·Dec 22, 2017
RecallFDA
Hetero Labs, Ltd. - Unit Iii
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufa...
Oral Drugs·0 affected·Dec 22, 2017
High RiskFDA
Hetero Labs Limited Unit V
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, H...
Oral Drugs·8,436 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue Fl...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-4570...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-...
Medical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-251...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) ...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Roche Diagnostics Corporation
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3...
Diagnostic Devices·47 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, P...
Surgical Devices·0 affected·Dec 22, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Medical Devices·2 affected·Dec 22, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to t...
Medical Devices·84 affected·Dec 22, 2017
CriticalFDA
California Popsicle, Inc.
Polly Ann Mango Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 28866 1
Dairy·541 affected·Dec 21, 2017
CriticalFDA
California Popsicle, Inc.
Polly Ann Red Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26868 7
Dairy·1,250 affected·Dec 21, 2017
High RiskFDA
Saputo Cheese Usa Inc.
Light String Cheese, Part Skim Mozzarella cheese, sold under the following brands and package sizes: 1. Fit & Active, 10 oz,., 12 in...
Dairy·36,071 affected·Dec 21, 2017
High RiskFDA
Nutricia North America
SHS Wel-Plan Wheat and Corn Strach Baking Mix , 400 g box,Cardboard carton, 18 cartons per case, but distributed by individual unit (car...
Food·506 affected·Dec 21, 2017
High RiskFDA
Casper's Ice Cream, Inc
Red Button Vintage Creamery, Caramel Cashew Ice Cream, 56 fluid ounce. UPC 077865010109. Case Pack UPC # 077865010109 AFS Item Number 64...
Dairy·847 affected·Dec 21, 2017
RecallFDA
Taro Pharmaceuticals U.s.a., Inc.
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist....
Topical Drugs·27,792 affected·Dec 21, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2...
Medical Devices·2,110 affected·Dec 21, 2017
High RiskFDA
W & H Dentalwerk Burmoos Gmbh - Site 1
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Medical Devices·0 affected·Dec 21, 2017
High RiskFDA
Baxter Healthcare Corporation
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Medical Devices·186 affected·Dec 21, 2017
High RiskFDA
Stryker Corporation
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used a...
Medical Devices·2 affected·Dec 21, 2017
RecallFDA
Quantimetrix Corporation
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is ...
Diagnostic Devices·20 affected·Dec 21, 2017
High RiskFDA
New Seasons Market
Buttermilk Herb Side Salad, prepacked in a clear plastic container, sold by the unit for $2.99, UPC 252326-602998.
Dairy·333 affected·Dec 20, 2017
CriticalFDA
Auromedics Pharma Llc
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, ...
Injectable Drugs·9,050 affected·Dec 20, 2017
High RiskFDA
Odan Laboratories Ltd
Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Derm...
Topical Drugs·21 affected·Dec 20, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 4923...
Drugs·3,734 affected·Dec 20, 2017
High RiskFDA
Odan Laboratories Ltd
Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cre...
Topical Drugs·179 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Ad-tech Medical Instrument Corporation
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long a...
Medical Devices·30 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal f...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH N...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAI...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Nidek Inc.
AUTO REF/KERATOMETER ARK-1s
Medical Devices·63 affected·Dec 20, 2017