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
Sun Pharma Global Fze
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Eli...
Ophthalmic Drugs·5,322 affected·Jan 21, 2015
CriticalFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
Injectable Drugs·661,128 affected·Jan 20, 2015
CriticalFDA
Pharmedium Services, Llc
fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, c...
Injectable Drugs·500 affected·Jan 13, 2015
CriticalFDA
Pharmedium Services, Llc
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code...
Injectable Drugs·180 affected·Jan 13, 2015
RecallFDA
Freedom Pharmaceuticals Inc
5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25...
Drugs·2 affected·Jan 8, 2015
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Adminis...
Injectable Drugs·126,075 affected·Dec 23, 2014
RecallFDA
Qualitest Pharmaceuticals
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UP...
Oral Drugs·3,936 affected·Dec 22, 2014
High RiskFDA
Neolpharma, Inc.
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 0...
Injectable Drugs·12,310 affected·Dec 17, 2014
High RiskFDA
American Specialty Pharmacy
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999...
Injectable Drugs·15 affected·Dec 12, 2014
RecallFDA
Pointe Scientific, Inc.
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R...
Diagnostic Devices·93 affected·Dec 12, 2014
RecallFDA
Akorn, Inc.
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Drugs·3,937 affected·Dec 9, 2014
CriticalFDA
Baxter Healthcare Corp
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Pr...
Injectable Drugs·542,080 affected·Dec 4, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micr...
Oral Drugs·13,488 affected·Dec 4, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: ...
Oral Drugs·240 affected·Dec 4, 2014
RecallFDA
Micro Labs Usa, Inc S
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micr...
Oral Drugs·13,464 affected·Dec 4, 2014
CriticalFDA
Hospira Inc.
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg...
Injectable Drugs·13,792 affected·Dec 3, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Cardiac Devices·1,553 affected·Nov 19, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Cardiac Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·5 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·509 affected·Nov 3, 2014
High RiskFDA
Baxter Healthcare Corp.
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for B...
Injectable Drugs·127,746 affected·Oct 30, 2014
High RiskFDA
Centurion Medical Products Corporation
Diagnostic Imaging Tray (General Surgery convenience kit)
Diagnostic Devices·760 affected·Oct 23, 2014
High RiskFDA
Prometheus Laboratories Inc.
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured b...
Oral Drugs·16,296 affected·Oct 22, 2014
CriticalFDA
Hospira Inc.
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) uni...
Injectable Drugs·100,100 affected·Oct 16, 2014
RecallFDA
Apotex Inc.
Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manu...
Oral Drugs·13,177 affected·Oct 16, 2014
RecallFDA
Apotex Inc.
Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured ...
Oral Drugs·22,710 affected·Oct 16, 2014
High RiskFDA
Pharmaceutical Associates Inc
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 2960...
Oral Drugs·9,640 affected·Oct 16, 2014
RecallFDA
Apotex Inc.
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured ...
Oral Drugs·11,062 affected·Oct 16, 2014
RecallFDA
Apotex Inc.
Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manu...
Oral Drugs·18,493 affected·Oct 16, 2014
RecallFDA
American Health Packaging
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- ...
Oral Drugs·2,005 affected·Oct 10, 2014
RecallFDA
Pfizer Inc.
TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed ...
Injectable Drugs·16,000 affected·Oct 10, 2014
High RiskFDA
Micro Labs Usa, Inc S
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by:...
Oral Drugs·11,328 affected·Oct 9, 2014
High RiskFDA
Teva Pharmaceuticals Usa
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet ...
Oral Drugs·19,545 affected·Oct 8, 2014
RecallFDA
Valeant Pharmaceuticals International
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 0...
Topical Drugs·1,663 affected·Oct 2, 2014
High RiskFDA
West-ward Pharmaceutical Corp.
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporate...
Oral Drugs·5,596 affected·Oct 2, 2014
RecallFDA
Sandoz, Inc
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratori...
Oral Drugs·6,336 affected·Oct 2, 2014
RecallFDA
Valeant Pharmaceuticals International
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016...
Topical Drugs·34,218 affected·Oct 2, 2014
RecallFDA
Gilead Sciences, Inc.
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Scien...
Oral Drugs·10,317 affected·Sep 30, 2014