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
Professional Disposables International, Inc
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -137...
Drugs·3,113 affected·Jul 23, 2021
High RiskFDA
Professional Disposables International, Inc
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S4135...
Drugs·41,105 affected·Jul 23, 2021
High RiskFDA
Native Promotions, Inc
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun...
Drugs·4,320 affected·Jul 12, 2021
High RiskFDA
The Harvard Drug Group
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose...
Oral Drugs·504 affected·Jul 2, 2021
High RiskFDA
Fresenius Kabi Usa Llc
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose...
Injectable Drugs·234,800 affected·Jun 25, 2021
RecallFDA
Teligent Pharma, Inc.
Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, ...
Topical Drugs·22,824 affected·Jun 22, 2021
High RiskFDA
Hoyu(us) Logistics Inc
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun...
Drugs·30,880 affected·Jun 22, 2021
RecallFDA
Teligent Pharma, Inc.
Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Topical Drugs·7,872 affected·Jun 22, 2021
CriticalFDA
Teva Pharmaceuticals Usa
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01...
Injectable Drugs·10,425 affected·Jun 18, 2021
RecallFDA
Grato Holdings, Inc.
B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1
Drugs·1,480 affected·Jun 18, 2021
High RiskFDA
Remel Inc
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Medical Devices·327 affected·Jun 18, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Respiratory Devices·255,810 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Respiratory Devices·72,665 affected·Jun 14, 2021
RecallFDA
Avkare Inc.
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Oral Drugs·10 affected·Jun 9, 2021
High RiskFDA
Genentech Inc
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of...
Injectable Drugs·88,620 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ir...
Oral Drugs·59,232 affected·Jun 9, 2021
High RiskFDA
World Source Llc
QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
Topical Drugs·6,300 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Irel...
Oral Drugs·696,396 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distribu...
Oral Drugs·350,985 affected·Jun 9, 2021
RecallFDA
Bausch Health Companies, Inc.
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewat...
Oral Drugs·2,691 affected·Jun 8, 2021
RecallFDA
Bausch Health Companies, Inc.
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals ...
Oral Drugs·37,797 affected·Jun 8, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 5...
Oral Drugs·5,984 affected·Jun 4, 2021
RecallFDA
American Health Packaging
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Colu...
Oral Drugs·290 affected·May 12, 2021
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactur...
Ophthalmic Drugs·0 affected·May 7, 2021
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelhe...
Oral Drugs·15,198 affected·May 4, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India,...
Oral Drugs·2,980 affected·May 4, 2021
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 421...
Oral Drugs·69,289 affected·Apr 29, 2021
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 421...
Oral Drugs·113,019 affected·Apr 29, 2021
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland...
Oral Drugs·3,138 affected·Apr 29, 2021
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, G...
Oral Drugs·154,726 affected·Apr 29, 2021
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharet...
Oral Drugs·79,344 affected·Apr 29, 2021
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 421...
Oral Drugs·66,155 affected·Apr 29, 2021
High RiskFDA
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: ...
Drugs·147 affected·Apr 28, 2021
RecallFDA
Kvk-tech, Inc.
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtow...
Oral Drugs·17,096 affected·Apr 27, 2021
High RiskFDA
Medivators, Inc.
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidne...
Medical Devices·1,381 affected·Apr 20, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 D...
Drugs·10,872 affected·Apr 16, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Flori...
Topical Drugs·12,060 affected·Apr 16, 2021
High RiskFDA
Preferred Pharmaceuticals, Inc.
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Pre...
Oral Drugs·0 affected·Apr 12, 2021
High RiskFDA
Teligent Pharma, Inc.
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Topical Drugs·3,432 affected·Apr 9, 2021
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles...
Oral Drugs·6,816 affected·Mar 26, 2021
RecallFDA
Sun Pharmaceutical Industries Inc
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, I...
Oral Drugs·2,520 affected·Mar 25, 2021
RecallFDA
Macleods Pharma Usa Inc
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, M...
Oral Drugs·8,015 affected·Mar 22, 2021
High RiskFDA
X-gen Pharmaceuticals Inc.
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14...
Oral Drugs·720 affected·Mar 19, 2021
High RiskFDA
Golden State Medical Supply Inc.
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA...
Oral Drugs·0 affected·Mar 19, 2021
High RiskFDA
Breckenridge Pharmaceutical, Inc
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, C...
Oral Drugs·3,146 affected·Mar 11, 2021
High RiskFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045...
Drugs·425,628 affected·Mar 9, 2021
High RiskFDA
Akorn, Inc.
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech...
Oral Drugs·8,183 affected·Mar 8, 2021
RecallFDA
Teva Pharmaceuticals Usa
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Drugs·1,416 affected·Mar 4, 2021