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
Warner Chilcott Us Llc
Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma S...
Oral Drugs188,600 affectedMay 17, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-5...
Oral Drugs14,503 affectedMay 16, 2013
RecallFDA
Novartis Consumer Health
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr...
Drugs3,768 affectedMay 15, 2013
Medium RiskFDA
Novartis Consumer Health
Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephr...
Drugs104,328 affectedMay 15, 2013
High RiskFDA
Novartis Consumer Health
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsi...
Drugs2,978,000 affectedMay 15, 2013
RecallFDA
Novartis Consumer Health
Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coat...
Drugs98,024 affectedMay 15, 2013
RecallFDA
Novartis Consumer Health
Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephr...
Drugs32,256 affectedMay 15, 2013
RecallFDA
Novartis Consumer Health
Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylep...
Drugs38,856 affectedMay 15, 2013
High RiskFDA
Actavis South Atlantic Llc
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed ...
Oral Drugs133,968 affectedMay 15, 2013
Medium RiskFDA
Novartis Consumer Health
Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 ...
Drugs167,712 affectedMay 15, 2013
RecallFDA
West-ward Pharmaceutical Corp.
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir,...
Injectable Drugs1,201 affectedMay 13, 2013
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distri...
Topical Drugs8,808 affectedMay 7, 2013
High RiskFDA
Hospira Inc.
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufact...
Injectable Drugs168,300 affectedMay 2, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC ...
Oral Drugs77,272 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 6...
Oral Drugs112,914 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC ...
Oral Drugs51,438 affectedApr 30, 2013
Medium RiskFDA
Hi-tech Pharmacal Co., Inc.
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 5...
Oral Drugs608,917 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 6...
Oral Drugs51,591 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC ...
Oral Drugs107,236 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 6...
Oral Drugs195,699 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC ...
Oral Drugs56,405 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC ...
Oral Drugs33,227 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 6...
Oral Drugs194,142 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC ...
Oral Drugs195,201 affectedApr 30, 2013
High RiskFDA
King Legacy, A Wholly Owned Subsidiary Of Pfizer
Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC ...
Oral Drugs103,796 affectedApr 30, 2013
High RiskFDA
Biomerieux Sa
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determinati...
Diagnostic Devices2,160 affectedApr 17, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 6...
Injectable Drugs245,250 affectedApr 8, 2013
RecallFDA
Hi-tech Pharmacal Co., Inc.
BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Ma...
Oral Drugs10,440 affectedApr 8, 2013
High RiskFDA
Cetylite Industries, Inc.
Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0...
Topical Drugs30 affectedApr 2, 2013
CriticalFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Injectable Drugs691,356 affectedMar 29, 2013
RecallFDA
Nestle Puerto Rico Inc
GERBER¿ Pure Water (1 Plastic Gallon)
Beverages12,948 affectedMar 19, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; M...
Oral Drugs3 affectedMar 18, 2013
RecallFDA
Physicians Total Care, Inc.
Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals...
Oral Drugs6 affectedMar 18, 2013
RecallFDA
Boehringer Ingelheim Roxane Inc
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) ...
Oral Drugs8,550 affectedMar 18, 2013
RecallFDA
Reckitt Benckiser Inc
Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, ND...
Drugs27,718 affectedMar 18, 2013
Medium RiskFDA
Teva Pharmaceuticals Usa, Inc.
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals U...
Oral Drugs154,536 affectedMar 15, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Bar...
Oral Drugs47,200 affectedMar 15, 2013
Medium RiskFDA
Teva Pharmaceuticals Usa, Inc.
Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, N...
Oral Drugs148,785 affectedMar 15, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals ...
Oral Drugs59,240 affectedMar 15, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, I...
Oral Drugs54,412 affectedMar 15, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona,...
Oral Drugs36,708 affectedMar 15, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, T...
Oral Drugs17,108 affectedMar 14, 2013
Medium RiskFDA
Teva Pharmaceuticals Usa, Inc.
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispe...
Oral Drugs120,049 affectedMar 14, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 d...
Oral Drugs71,893 affectedMar 12, 2013
RecallFDA
L. Perrigo Co.
Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, ...
Oral Drugs21,667 affectedMar 12, 2013
RecallFDA
Teva Pharmaceuticals Usa, Inc.
Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 w...
Oral Drugs17,661 affectedMar 12, 2013
RecallFDA
Hi-tech Pharmacal Co., Inc.
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383...
Drugs11,472 affectedMar 11, 2013
High RiskFDA
Gsms
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only...
Oral Drugs6,158 affectedMar 11, 2013