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
Valeant Pharmacueticals International
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for th...
Respiratory Devices·418 affected·Mar 13, 2017
RecallFDA
Pfizer Inc
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pha...
Oral Drugs·11,862 affected·Mar 7, 2017
RecallFDA
Pfizer Inc
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Phar...
Oral Drugs·28,938 affected·Mar 7, 2017
RecallFDA
Pfizer Inc
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pha...
Oral Drugs·9,666 affected·Mar 7, 2017
RecallFDA
Teva Pharmaceuticals Usa
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carto...
Oral Drugs·25,916 affected·Feb 17, 2017
High RiskFDA
Avkare Inc.
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 502...
Oral Drugs·116 affected·Feb 15, 2017
RecallFDA
L. Perrigo Company
Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, ...
Topical Drugs·10,656 affected·Feb 13, 2017
RecallFDA
L. Perrigo Company
Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, ND...
Drugs·10,656 affected·Feb 13, 2017
High RiskFDA
Amerisource Health Services
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- ND...
Oral Drugs·454 affected·Feb 8, 2017
CriticalFDA
X-gen Pharmaceuticals Inc.
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per c...
Injectable Drugs·2,593 affected·Feb 8, 2017
High RiskFDA
G & W Laboratories, Inc.
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. ...
Drugs·3,456 affected·Feb 7, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., N...
Oral Drugs·7,628 affected·Feb 7, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 7000...
Injectable Drugs·30 affected·Feb 3, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC ...
Injectable Drugs·716 affected·Feb 3, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70...
Injectable Drugs·490 affected·Feb 3, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
Injectable Drugs·62 affected·Feb 3, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 700...
Injectable Drugs·386 affected·Feb 3, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Littl...
Injectable Drugs·50 affected·Feb 3, 2017
High RiskFDA
Apotex Inc.
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Ap...
Oral Drugs·19,584 affected·Feb 3, 2017
CriticalFDA
Sca Pharmaceuticals
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-092...
Injectable Drugs·50 affected·Feb 3, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3...
Oral Drugs·17,473 affected·Feb 2, 2017
High RiskFDA
Actavis Inc
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 US...
Oral Drugs·499,320 affected·Jan 30, 2017
CriticalFDA
Hospira Inc., A Pfizer Company
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in ...
Injectable Drugs·30,880 affected·Jan 24, 2017
RecallFDA
Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Drugs·2,568 affected·Jan 16, 2017
High RiskFDA
Abbvie Inc.
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., N...
Drugs·4,021 affected·Jan 13, 2017
Medium RiskFDA
Actavis Inc
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92...
Drugs·164,844 affected·Jan 12, 2017
High RiskFDA
Innovagel
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami,...
Oral Drugs·7,920,177 affected·Jan 5, 2017
High RiskFDA
Innovagel
Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186...
Oral Drugs·9,992,768 affected·Jan 5, 2017
RecallFDA
Mckesson Packaging Services
Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc....
Oral Drugs·476 affected·Jan 4, 2017
RecallFDA
The Harvard Drug Group
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major ...
Oral Drugs·36,990 affected·Dec 27, 2016
High RiskFDA
Sandoz Incorporated
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Oral Drugs·96 affected·Dec 22, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, S...
Oral Drugs·133,601 affected·Dec 21, 2016
RecallFDA
Apotex Inc.
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: ...
Oral Drugs·67,946 affected·Dec 19, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 6017...
Injectable Drugs·47 affected·Dec 16, 2016
RecallFDA
Roxane Laboratories, Inc.
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West...
Inhaled / Nasal Drugs·74,108 affected·Dec 14, 2016
RecallFDA
Sandoz Inc
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), ...
Oral Drugs·10,200 affected·Dec 13, 2016
High RiskFDA
On-x Life Technologies, Inc.
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve...
Medical Implants·45 affected·Dec 13, 2016
RecallFDA
Novum Pharma, Llc
Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10...
Topical Drugs·6,763 affected·Dec 7, 2016
RecallFDA
Cipher Pharmaceuticals Us Llc
INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide ...
Oral Drugs·216 affected·Dec 6, 2016
RecallFDA
Ecolab, Inc.
Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model N...
Drugs·427 affected·Dec 2, 2016
Medium RiskFDA
Pfizer Inc.
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distribute...
Injectable Drugs·582,165 affected·Nov 22, 2016
RecallFDA
West-ward Pharmaceuticals Corp.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farm...
Injectable Drugs·5,142 affected·Nov 17, 2016
High RiskFDA
Pfizer Inc.
LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceutica...
Oral Drugs·2,666 affected·Nov 7, 2016
RecallFDA
Mylan Pharmaceuticals Inc.
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, M...
Oral Drugs·51,983 affected·Nov 3, 2016
RecallFDA
Teva Pharmaceuticals Usa
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA...
Inhaled / Nasal Drugs·201 affected·Nov 1, 2016
RecallFDA
Teva Pharmaceuticals Usa
Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA...
Inhaled / Nasal Drugs·0 affected·Nov 1, 2016
Medium RiskFDA
Sun Pharmaceutical Industries, Inc.
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, ...
Topical Drugs·326,103 affected·Oct 28, 2016
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 00622...
Medical Devices·2,619 affected·Oct 28, 2016