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
Terumo Cardiovascular Systems Corporation
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula ...
Medical Devices·6,720 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Ven...
Medical Devices·34,470 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusio...
Medical Devices·120 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion o...
Medical Devices·3,040 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: ...
Medical Devices·2,290 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicate...
Medical Devices·135,340 affected·May 23, 2014
High RiskFDA
Cambrex Charles City Inc
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboa...
Drugs·2,351 affected·May 20, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGe...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen...
Medical Implants·41,180 affected·May 19, 2014
High RiskFDA
Actavis Inc
Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Pars...
Oral Drugs·6,913 affected·May 16, 2014
High RiskFDA
Hospira Inc.
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc....
Injectable Drugs·45,448 affected·May 16, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for ...
Medical Devices·681 affected·May 14, 2014
CriticalFDA
Bristol-meyers Squibb
COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Pri...
Injectable Drugs·50,724 affected·May 12, 2014
CriticalFDA
Baxter Healthcare Corp.
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
Injectable Drugs·4,200 affected·May 12, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manuf...
Injectable Drugs·2,070,500 affected·May 2, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Man...
Injectable Drugs·728,880 affected·May 2, 2014
High RiskFDA
Alere San Diego, Inc.
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Aler...
Diagnostic Devices·373 affected·May 2, 2014
High RiskFDA
Boehringer Ingelheim Roxane Inc
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Oral Drugs·5,364 affected·May 1, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Oral Drugs·9,882 affected·May 1, 2014
CriticalFDA
Hospira Inc.
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest,...
Injectable Drugs·85,680 affected·Apr 21, 2014
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA...
Injectable Drugs·211,752 affected·Apr 21, 2014
RecallFDA
Apotex Corp.
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manu...
Oral Drugs·5,397 affected·Apr 18, 2014
CriticalFDA
Hospira Inc.
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, In...
Injectable Drugs·120,900 affected·Apr 18, 2014
CriticalFDA
Cubist Pharmaceuticals, Inc.
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421...
Injectable Drugs·51,500 affected·Apr 17, 2014
High RiskFDA
Wockhardt Usa Inc.
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64...
Oral Drugs·1,118,400 affected·Apr 17, 2014
Medium RiskFDA
Fresenius Kabi Usa Llc
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Injectable Drugs·216,517 affected·Apr 14, 2014
High RiskFDA
P&l Developments, Llc
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, O...
Drugs·2,500,510 affected·Apr 14, 2014
Medium RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Oral Drugs·128,363 affected·Apr 9, 2014
RecallFDA
Caraco Pharmaceutical Laboratories, Ltd.
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distribu...
Oral Drugs·47,813 affected·Apr 9, 2014
High RiskFDA
Teva Pharmaceuticals Usa
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 00...
Oral Drugs·53,452 affected·Apr 7, 2014
High RiskFDA
Teva Pharmaceuticals Usa
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 00...
Oral Drugs·17,181 affected·Apr 7, 2014
CriticalFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira...
Injectable Drugs·844,300 affected·Apr 2, 2014
High RiskFDA
Teva Pharmaceuticals Usa
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack...
Oral Drugs·89,215 affected·Apr 1, 2014
RecallFDA
Genesis Pharmaceutical, Inc.
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a ...
Drugs·461 affected·Apr 1, 2014
High RiskFDA
Hi-tech Pharmacal Co., Inc.
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech ...
Oral Drugs·451,916 affected·Apr 1, 2014
High RiskFDA
Hospira Inc.
Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lak...
Injectable Drugs·255,900 affected·Mar 27, 2014
CriticalFDA
Pharmakon Pharmaceuticals
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz ...
Drugs·80 affected·Mar 26, 2014
RecallFDA
Apotex Inc.
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured fo...
Oral Drugs·11,422 affected·Mar 20, 2014
High RiskFDA
John W Hollis Inc
Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Drugs·3 affected·Mar 17, 2014
CriticalFDA
Shire Human Genetic Therapies, Inc.
VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Wa...
Injectable Drugs·8,359 affected·Mar 14, 2014
High RiskFDA
Paddock Laboratories, Llc
Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01
Oral Drugs·156,012 affected·Mar 11, 2014
High RiskFDA
Neusoft Medical System Co
Neusoft NeuViz 64 Multi-slice CT Scanner System
Medical Devices·5 affected·Mar 8, 2014
RecallFDA
Mckesson Packaging Services
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceut...
Oral Drugs·1,557 affected·Mar 3, 2014