Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
High RiskFDA
Biocardia, Inc.
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 ...
Surgical Devices·2,541 affected·Mar 3, 2014
RecallFDA
Pfizer Us Pharmaceutical Group
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Drugs·70,704 affected·Feb 26, 2014
RecallFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKl...
Topical Drugs·150 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette,...
Drugs·488,628 affected·Feb 20, 2014
RecallFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKl...
Drugs·12,162 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKlin...
Drugs·189,900 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distrib...
Drugs·109,848 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette,...
Drugs·603,696 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Dist...
Drugs·834,072 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline...
Drugs·146,424 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmit...
Drugs·147,684 affected·Feb 20, 2014
Medium RiskFDA
Glaxosmithkline Consumer Healthcare; Dba-glaxosmithkline
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, D...
Drugs·304,332 affected·Feb 20, 2014
RecallFDA
Gilead Sciences, Inc.
Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured...
Oral Drugs·39,223 affected·Feb 19, 2014
CriticalFDA
Ben Venue Laboratories Inc
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Drugs·5,131 affected·Feb 14, 2014
High RiskFDA
Agila Specialties Private Ltd.
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per...
Injectable Drugs·7,919 affected·Feb 14, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patc...
Topical Drugs·117,600 affected·Feb 13, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park...
Drugs·10 affected·Feb 13, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count pat...
Topical Drugs·187,860 affected·Feb 13, 2014
Medium RiskFDA
Teva Pharmaceuticals Usa
QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 ...
Drugs·257,832 affected·Feb 11, 2014
High RiskFDA
Hospira Inc.
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 04...
Drugs·115,500 affected·Feb 10, 2014
RecallFDA
Actavis
Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven h...
Topical Drugs·38,227 affected·Feb 7, 2014
RecallFDA
Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc....
Topical Drugs·4,142 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuti...
Topical Drugs·8,734 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton ...
Drugs·13,591 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Ro...
Drugs·13,379 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermace...
Topical Drugs·14,226 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. ...
Drugs·4,080 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Derm...
Topical Drugs·8,734 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. ...
Topical Drugs·7,676 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals ...
Drugs·7,292 affected·Jan 31, 2014
RecallFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qu...
Oral Drugs·3,252 affected·Jan 28, 2014
RecallFDA
Lupin Pharmaceuticals Inc.
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc....
Oral Drugs·5,172 affected·Jan 27, 2014
RecallFDA
Lupin Pharmaceuticals Inc.
Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 11...
Oral Drugs·4,038 affected·Jan 27, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-5...
Injectable Drugs·161,650 affected·Jan 22, 2014
High RiskFDA
Mylan Pharmaceuticals Inc.
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, ND...
Oral Drugs·138,970 affected·Jan 14, 2014
CriticalFDA
Hospira Inc.
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 6004...
Injectable Drugs·123,900 affected·Jan 10, 2014
High RiskFDA
Watson Laboratories Inc
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 7...
Injectable Drugs·4,439 affected·Dec 23, 2013
CriticalFDA
Hospira Inc.
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Fore...
Injectable Drugs·68,350 affected·Dec 23, 2013
High RiskFDA
Aesculap, Inc.
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from t...
Medical Devices·79 affected·Dec 23, 2013
High RiskFDA
Carefusion 2200 Inc
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hil...
Drugs·1,662,000 affected·Dec 20, 2013
High RiskFDA
Carefusion 2200 Inc
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hill...
Drugs·2,443,500 affected·Dec 20, 2013
High RiskFDA
Teva Pharmaceuticals Usa
Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Ko...
Oral Drugs·1,249,700 affected·Dec 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o....
Oral Drugs·112,800 affected·Dec 18, 2013
Medium RiskFDA
Qualitest Pharmaceuticals
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Quali...
Oral Drugs·438,055 affected·Dec 16, 2013
High RiskFDA
Corepharma Llc
Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 0884...
Oral Drugs·174,888 affected·Dec 13, 2013
High RiskFDA
Hospira Inc.
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx...
Drugs·126,425 affected·Dec 12, 2013
Medium RiskFDA
Fresenius Kabi Usa, Llc
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 6...
Injectable Drugs·215,340 affected·Dec 6, 2013
CriticalFDA
Baxter Healthcare Corp.
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 U...
Injectable Drugs·105,216 affected·Nov 21, 2013