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
Kremers Urban Pharmaceuticals, Inc.
Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: ...
Topical Drugs·16,504 affected·Jul 7, 2015
High RiskFDA
Kremers Urban Pharmaceuticals, Inc.
Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: ...
Topical Drugs·16,832 affected·Jul 7, 2015
RecallFDA
Biocomp Pharma, Inc.
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet,...
Drugs·40,000 affected·Jul 6, 2015
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Sal...
Oral Drugs·19,504 affected·Jun 24, 2015
RecallFDA
Qualitest Pharmaceuticals
Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsvil...
Oral Drugs·2,016 affected·Jun 18, 2015
High RiskFDA
B. Braun Interventional Systems
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable ...
Medical Implants·11 affected·Jun 16, 2015
High RiskFDA
The Harvard Drug Group, Llc
OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63...
Oral Drugs·12,717 affected·Jun 10, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 6...
Injectable Drugs·7,593 affected·Jun 4, 2015
RecallFDA
Indiana Botanic Gardens, Inc
Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578...
Topical Drugs·630 affected·Jun 4, 2015
High RiskFDA
Baxter Healthcare Corp
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare...
Injectable Drugs·145,350 affected·Jun 3, 2015
RecallFDA
Bracco Diagnostic Inc
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidi...
Drugs·1,008 affected·May 27, 2015
CriticalFDA
Pharmedium Services, Llc
Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, ...
Injectable Drugs·19 affected·May 22, 2015
High RiskFDA
Mylan Lab Inc
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., N...
Oral Drugs·7,722 affected·May 20, 2015
RecallFDA
West-ward Pharmaceutical Corp.
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dos...
Injectable Drugs·14,649 affected·May 13, 2015
CriticalFDA
Ethicon Endo-surgery Inc
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system int...
Medical Devices·14 affected·May 13, 2015
Medium RiskFDA
Teva Pharmaceuticals Usa
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhal...
Oral Drugs·233,364 affected·May 7, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (ND...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limite...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Dr. Reddy's Laboratories, Inc.
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC ...
Oral Drugs·0 affected·May 6, 2015
RecallFDA
Ohm Laboratories, Inc.
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister...
Oral Drugs·2,592 affected·May 4, 2015
RecallFDA
Medop Health, Inc.
***MaxiFlex (Registered)***Multinutrient Formula***Maximum Joint Support***MedOp, Inc.***Dietary Supplement ***120 Vegetable Capsules***D...
Produce·638 affected·Apr 30, 2015
High RiskFDA
Janssen Pharmaceuticals, Inc.
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 bl...
Oral Drugs·16,861 affected·Apr 29, 2015
CriticalFDA
Teva Pharmaceuticals Usa
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx ...
Injectable Drugs·6,195 affected·Apr 28, 2015
Medium RiskFDA
Cipla Limited
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampu...
Drugs·140,625 affected·Apr 24, 2015
CriticalFDA
Mylan Institutional Llc
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0...
Injectable Drugs·8,340 affected·Apr 23, 2015
CriticalFDA
Hospira Inc.
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL ...
Drugs·150,950 affected·Apr 23, 2015
RecallFDA
Valeant Pharmaceuticals North America Llc
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant P...
Oral Drugs·6,321 affected·Apr 18, 2015
Medium RiskFDA
Valeant Pharmaceuticals North America Llc
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals...
Oral Drugs·564,454 affected·Apr 18, 2015
High RiskFDA
Valeant Pharmaceuticals North America Llc
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA...
Oral Drugs·93,237 affected·Apr 17, 2015
High RiskFDA
Sandoz, Inc
Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manu...
Oral Drugs·1,023,430 affected·Apr 15, 2015
RecallFDA
Actavis Laboratories
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Com...
Drugs·78,522 affected·Apr 14, 2015
CriticalFDA
Pharmedium Services, Llc
HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx o...
Injectable Drugs·480 affected·Apr 13, 2015
CriticalFDA
Pharmedium Services, Llc
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Ser...
Injectable Drugs·264 affected·Apr 13, 2015
CriticalFDA
Pharmedium Services, Llc
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Se...
Injectable Drugs·48 affected·Apr 13, 2015
CriticalFDA
Pharmedium Services, Llc
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport ...
Injectable Drugs·72 affected·Apr 13, 2015
CriticalFDA
Pharmedium Services, Llc
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Serv...
Injectable Drugs·36 affected·Apr 13, 2015
CriticalFDA
Pharmedium Services, Llc
HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx o...
Injectable Drugs·240 affected·Apr 13, 2015
RecallFDA
Apotex Inc.
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Oral Drugs·5,352 affected·Apr 7, 2015
RecallFDA
Apotex Inc.
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx on...
Oral Drugs·6,467 affected·Apr 7, 2015
High RiskFDA
Akorn, Inc.
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc....
Oral Drugs·0 affected·Apr 7, 2015
RecallFDA
Apotex Inc.
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx onl...
Oral Drugs·23,274 affected·Apr 7, 2015
High RiskFDA
Akorn, Inc.
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA...
Oral Drugs·424,174 affected·Apr 7, 2015
High RiskFDA
Boehringer Ingelheim Roxane Inc
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Oh...
Oral Drugs·575 affected·Apr 2, 2015
RecallFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by:...
Oral Drugs·1,363 affected·Mar 26, 2015
RecallFDA
Qualitest Pharmaceuticals
PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydro...
Drugs·36,732 affected·Mar 25, 2015
High RiskFDA
Heritage Pharmaceuticals, Inc.
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals I...
Oral Drugs·6,816 affected·Mar 25, 2015
CriticalFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road M...
Injectable Drugs·202,824 affected·Mar 24, 2015