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
CriticalFDA
B. Braun Medical Inc
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical I...
Injectable Drugs·53,592 affected·Nov 21, 2013
CriticalFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) ...
Injectable Drugs·716,544 affected·Nov 21, 2013
CriticalFDA
B. Braun Medical Inc
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical...
Injectable Drugs·42,576 affected·Nov 21, 2013
CriticalFDA
Baxter Healthcare Corp.
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1...
Injectable Drugs·49,932 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter ...
Injectable Drugs·7,388 affected·Nov 18, 2013
RecallFDA
Fougera Pharmaceuticals Inc.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, ND...
Topical Drugs·31,122 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber...
Injectable Drugs·7,068 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Bax...
Injectable Drugs·14,574 affected·Nov 18, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening ...
Diagnostic Devices·2,874 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations fo...
Diagnostic Devices·164 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative...
Diagnostic Devices·1,961 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
Medical Devices·768 affected·Nov 8, 2013
High RiskFDA
Actavis Elizabeth Llc
Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-...
Oral Drugs·13,608 affected·Nov 6, 2013
RecallFDA
Sandoz Inc
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, ...
Oral Drugs·11,496 affected·Nov 6, 2013
RecallFDA
Greenstone Llc
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- N...
Oral Drugs·22,529 affected·Nov 4, 2013
CriticalFDA
Alexion Pharmaceuticals, Inc.
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufa...
Injectable Drugs·21,661 affected·Nov 4, 2013
High RiskFDA
Fresenius Kabi Usa, Llc
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for:...
Injectable Drugs·121,456 affected·Oct 31, 2013
High RiskFDA
Teva Pharmaceuticals Usa
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcoho...
Injectable Drugs·6,803 affected·Oct 24, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD ...
Medical Devices·30 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD ...
Medical Devices·70 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass...
Medical Devices·40 affected·Oct 23, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD wi...
Medical Devices·90 affected·Oct 23, 2013
CriticalFDA
Hospira Inc.
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx on...
Injectable Drugs·40,360 affected·Oct 18, 2013
RecallFDA
Taro Pharmaceuticals U.s.a., Inc.
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by...
Drugs·850 affected·Oct 16, 2013
High RiskFDA
Vistapharm, Inc.
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo...
Oral Drugs·27,788 affected·Oct 15, 2013
High RiskFDA
Sandoz Inc
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Oral Drugs·2,491 affected·Oct 11, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable 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 ...
Injectable Drugs·70,450 affected·Oct 11, 2013
High RiskFDA
Amedra Pharmaceuticals Llc
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pha...
Oral Drugs·10,992 affected·Oct 7, 2013
RecallFDA
Lin-zhi International Inc
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. ...
Diagnostic Devices·60 affected·Oct 3, 2013
Medium RiskFDA
Tolmar, Inc.
Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Drugs·391,055 affected·Sep 23, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Ph...
Injectable Drugs·9,813 affected·Sep 23, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pha...
Injectable Drugs·9,020 affected·Sep 23, 2013
High RiskFDA
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States...
Oral Drugs·22 affected·Sep 17, 2013
High RiskFDA
Amgen, Inc.
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing ...
Injectable Drugs·4,163 affected·Sep 17, 2013
High RiskFDA
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States ...
Oral Drugs·30,264 affected·Sep 17, 2013
CriticalFDA
Hospira, Inc.
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Injectable Drugs·374,500 affected·Sep 16, 2013
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distribu...
Topical Drugs·0 affected·Sep 8, 2013
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distribu...
Topical Drugs·0 affected·Sep 8, 2013
High RiskFDA
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by...
Oral Drugs·197,532 affected·Sep 6, 2013
RecallFDA
Hi-tech Pharmacal Co., Inc.
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTIT...
Inhaled / Nasal Drugs·50,848 affected·Sep 4, 2013
CriticalFDA
Hospira Inc.
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, ...
Injectable Drugs·17,256 affected·Aug 30, 2013
High RiskFDA
Hospira Inc.
5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
Injectable Drugs·86,400 affected·Aug 29, 2013
CriticalFDA
Cubist Pharmaceuticals, Inc.
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, ...
Injectable Drugs·179,870 affected·Aug 29, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only,...
Injectable Drugs·283,150 affected·Aug 14, 2013
High RiskFDA
Novocol Pharmaceutical Of Canada
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - ...
Injectable Drugs·12,497 affected·Aug 14, 2013
High RiskFDA
American Health Packaging
Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Col...
Oral Drugs·1,536 affected·Aug 2, 2013
High RiskFDA
Nexus Pharmaceuticals Inc
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceutical...
Injectable Drugs·46,185 affected·Aug 1, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Ma...
Oral Drugs·1,000 affected·Jul 30, 2013