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
RecallFDA
Leadiant Biosciences, Inc
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 ...
Ophthalmic Drugs·1,705 affected·Feb 14, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Is...
Oral Drugs·1,157,095 affected·Feb 5, 2018
High RiskFDA
3m Company - Health Care Business
3M Surgical Clipper Professional 9681
Surgical Devices·120,000 affected·Feb 2, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, IN...
Oral Drugs·34,125 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-12...
Oral Drugs·12,579 affected·Jan 29, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·1,118,046 affected·Jan 29, 2018
RecallFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT,...
Drugs·554 affected·Jan 29, 2018
Medium RiskFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·929,916 affected·Jan 29, 2018
RecallFDA
Mckesson Packaging Services
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a ...
Oral Drugs·24,120 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, IN...
Oral Drugs·28,941 affected·Jan 29, 2018
RecallFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, ...
Drugs·576 affected·Jan 29, 2018
RecallFDA
Oxygen Development Llc
Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W...
Drugs·12,216 affected·Jan 24, 2018
RecallFDA
Fresenius Kabi Usa, Llc
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Injectable Drugs·35,620 affected·Jan 16, 2018
CriticalFDA
Auromedics Pharma Llc
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics...
Injectable Drugs·6,072 affected·Jan 12, 2018
High RiskFDA
Avkare Inc.
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-51...
Oral Drugs·237 affected·Jan 3, 2018
CriticalFDA
Auromedics Pharma Llc
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, ...
Injectable Drugs·9,050 affected·Dec 20, 2017
RecallFDA
Osmotica Pharmaceutical Corp
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ...
Oral Drugs·10,064 affected·Dec 18, 2017
RecallFDA
Osmotica Pharmaceutical Corp
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ ...
Oral Drugs·9,919 affected·Dec 18, 2017
High RiskFDA
B. Braun Medical Inc
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-230...
Drugs·2,576 affected·Dec 15, 2017
High RiskFDA
Amneal Pharmaceuticals
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-...
Injectable Drugs·12,584 affected·Dec 15, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTI...
Oral Drugs·4,969 affected·Dec 14, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit th...
Surgical Devices·31,005 affected·Dec 11, 2017
CriticalFDA
Auromedics Pharma Llc
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheelin...
Injectable Drugs·66,100 affected·Dec 4, 2017
High RiskFDA
Allergan
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufac...
Oral Drugs·12,699 affected·Dec 4, 2017
RecallFDA
Teva Pharmaceuticals Usa
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada B...
Oral Drugs·42,384 affected·Nov 28, 2017
RecallFDA
Elite Laboratories Inc.
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263...
Oral Drugs·1,264 affected·Nov 13, 2017
RecallFDA
Renaissance Lakewood, Llc
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris Li...
Injectable Drugs·24,569 affected·Nov 11, 2017
RecallFDA
West-ward Pharmaceuticals Corp.
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 06...
Injectable Drugs·16,157 affected·Nov 6, 2017
RecallFDA
Claris Lifesciences Inc
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: C...
Injectable Drugs·0 affected·Nov 6, 2017
RecallFDA
West-ward Pharmaceuticals Corp.
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf...
Injectable Drugs·1,896 affected·Nov 6, 2017
RecallFDA
Mylan Pharmaceuticals Inc.
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S....
Oral Drugs·1,414 affected·Nov 3, 2017
High RiskFDA
Pharmedium Services, Llc
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count ...
Drugs·5,002 affected·Oct 30, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-...
Oral Drugs·140,993 affected·Oct 25, 2017
High RiskFDA
Pfizer Inc.
Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-49...
Oral Drugs·1,972 affected·Oct 20, 2017
CriticalFDA
Pfizer Inc.
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bo...
Oral Drugs·183,437 affected·Oct 20, 2017
Medium RiskFDA
Allergan Sales, Llc
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL ...
Ophthalmic Drugs·715,041 affected·Oct 19, 2017
Medium RiskFDA
Allergan Sales, Llc
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Ophthalmic Drugs·153,616 affected·Oct 19, 2017
RecallFDA
Teva Pharmaceuticals Usa
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 928...
Oral Drugs·58,292 affected·Oct 17, 2017
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, graphite block 8
Medical Devices·3 affected·Oct 17, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a p...
Medical Devices·28 affected·Oct 16, 2017
High RiskFDA
Pharmedium Services, Llc.
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. ...
Injectable Drugs·499 affected·Oct 13, 2017
High RiskFDA
Avkare Inc.
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Ma...
Oral Drugs·274 affected·Oct 6, 2017
High RiskFDA
Purdue Pharma, Lp
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Drugs·3,997 affected·Oct 5, 2017
Medium RiskFDA
Dr. Reddy's Laboratories, Inc.
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by...
Oral Drugs·569,376 affected·Oct 3, 2017
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne,...
Oral Drugs·96,876 affected·Oct 2, 2017
High RiskFDA
United Pharmacy
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N....
Injectable Drugs·268 affected·Sep 27, 2017
High RiskFDA
Pharmedium Services, Llc
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland...
Drugs·2,390 affected·Sep 26, 2017
High RiskFDA
The Harvard Drug Group
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna,...
Oral Drugs·3,935 affected·Sep 26, 2017